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Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold (PIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339726
Recruitment Status : Terminated (did not enroll enough subjects in the 2017/2018 cold season, so the study was terminated)
First Posted : November 13, 2017
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Common Cold
Interventions Drug: New Formulation Phenylephrine HCl
Drug: Marketed Phenylephrine HCl
Drug: Placebo
Enrollment 193
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Period Title: Overall Study
Started 64 66 63
Completed 63 65 63
Not Completed 1 1 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Lost to Follow-up             0             1             0
Arm/Group Title Placebo PE-IR PE-ER Total
Hide Arm/Group Description One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily. Total of all reporting groups
Overall Number of Baseline Participants 64 66 63 193
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 66 participants 63 participants 193 participants
44.7  (14.60) 43.4  (14.71) 46.4  (15.44) 44.8  (14.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 63 participants 193 participants
Female
47
  73.4%
37
  56.1%
38
  60.3%
122
  63.2%
Male
17
  26.6%
29
  43.9%
25
  39.7%
71
  36.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 63 participants 193 participants
Hispanic or Latino
5
   7.8%
2
   3.0%
3
   4.8%
10
   5.2%
Not Hispanic or Latino
59
  92.2%
64
  97.0%
60
  95.2%
183
  94.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 63 participants 193 participants
American Indian or Alaska Native
2
   3.1%
3
   4.5%
1
   1.6%
6
   3.1%
Asian
7
  10.9%
11
  16.7%
7
  11.1%
25
  13.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.1%
3
   4.5%
0
   0.0%
5
   2.6%
White
50
  78.1%
48
  72.7%
53
  84.1%
151
  78.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   4.7%
1
   1.5%
2
   3.2%
6
   3.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
North America Number Analyzed 64 participants 66 participants 63 participants 193 participants
CAN
64
 100.0%
66
 100.0%
63
 100.0%
193
 100.0%
1.Primary Outcome
Title Mean Change From Baseline in the Nasal Congestion Severity Score
Hide Description Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours.
Time Frame 0-12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.80  (0.156) 2.03  (0.154) 1.93  (0.158)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.205 to 0.662
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.220
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.311 to 0.564
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.222
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.537 to 0.333
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.220
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Average Change From Baseline in the Nasal Congestion Severity Score
Hide Description Average change from baseline in the Nasal Congestion Severity Score averaged over hours 8-12. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.14  (0.185) 2.39  (0.182) 2.16  (0.187)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.267 to 0.759
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.260
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.938
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.498 to 0.539
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.263
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.741 to 0.289
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.261
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Nasal Congestion Severity Score
Hide Description Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.12  (0.163) 1.24  (0.161) 1.52  (0.165)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.607
Comments [Not Specified]
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.33 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.230
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-0.06 to 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.232
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.17 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.230
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Nasal Congestion Severity Score
Hide Description Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.69  (0.193) 1.82  (0.190) 1.71  (0.194)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.40 to 0.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.271
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.952
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.52 to 0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.273
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.678
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.65 to 0.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.272
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Nasal Congestion Severity Score
Hide Description Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.58  (0.178) 1.97  (0.176) 1.86  (0.180)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
-0.11 to 0.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.250
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.22 to 0.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.253
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.60 to 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.251
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Nasal Congestion Severity Score
Hide Description Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.00  (0.188) 2.22  (0.185) 1.99  (0.189)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.31 to 0.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.264
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.970
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.54 to 0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.266
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.74 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.265
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Nasal Congestion Severity Score
Hide Description Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.14  (0.193) 2.45  (0.191) 2.18  (0.195)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-0.23 to 0.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.272
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.877
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.50 to 0.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.275
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.329
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.80 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.273
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Nasal Congestion Severity Score
Hide Description Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.28  (0.212) 2.50  (0.209) 2.31  (0.214)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.469
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.37 to 0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.298
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.924
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.57 to 0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.301
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.532
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.78 to 0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.299
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Nasal Congestion Severity Score
Hide Description Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.78  (0.220) 2.61  (0.217) 2.52  (0.222)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.579
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.78 to 0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.309
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.394
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.88 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.312
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.760
Comments The significance threshold level was 0.05 (two sided).
Method ANOVA
Comments Treatment and baseline nasal congestion score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.71 to 0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.310
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Average Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores averaged over assessments at 2, 4, 6, 8, 10, and 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.67  (0.155) 1.78  (0.152) 1.74  (0.156)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.616
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.320 to 0.539
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.218
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.734
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.359 to 0.508
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.220
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.874
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.465 to 0.395
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.218
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.10  (0.163) 1.03  (0.161) 1.30  (0.164)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.750
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.53 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.230
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.390
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.26 to 0.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.232
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.18 to 0.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.230
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.
Time Frame 0-4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.54  (0.190) 1.43  (0.187) 1.48  (0.191)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.707
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.63 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.267
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.839
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.59 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.269
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.864
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.48 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.267
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.62  (0.181) 1.69  (0.179) 1.75  (0.182)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.794
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.44 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.255
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.628
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.38 to 0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.257
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.45 to 0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.255
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
1.69  (0.189) 1.95  (0.186) 1.82  (0.190)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
-0.27 to 0.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.266
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.631
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.40 to 0.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.269
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.66 to 0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.266
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on scale
1.91  (0.196) 2.23  (0.193) 1.96  (0.197)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.240
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
-0.22 to 0.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.275
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.865
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.50 to 0.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.278
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.82 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.275
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.15  (0.202) 2.32  (0.199) 2.15  (0.203)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.529
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.38 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.284
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.56 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.287
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.532
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.74 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.285
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Sinus Pressure/Tenderness Scores
Hide Description Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe.
Time Frame 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description:
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
Overall Number of Participants Analyzed 64 66 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.61  (0.220) 2.39  (0.216) 2.23  (0.221)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PE-IR
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.468
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.83 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.309
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-1.00 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.312
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PE-IR, PE-ER
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments The significance threshold level was 0.05 (two sided).
Method ANCOVA
Comments Treatment and baseline sinus pressure/tenderness score were factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.77 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.309
Estimation Comments [Not Specified]
Time Frame Within three days for nonserious adverse events, +30 days after the participant's last dose or exposure to the investigational product for serious adverse events.
Adverse Event Reporting Description AEs were systematically collected during the study and at the follow-up visit at Day 2 (+/-1 day). Spontaneously reported AEs collected during the study were also recorded. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint.
 
Arm/Group Title Placebo PE-IR PE-ER
Hide Arm/Group Description One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
All-Cause Mortality
Placebo PE-IR PE-ER
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/66 (0.00%)   0/63 (0.00%) 
Hide Serious Adverse Events
Placebo PE-IR PE-ER
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/66 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo PE-IR PE-ER
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/66 (0.00%)   0/63 (0.00%) 
An interim statistical analysis was conducted after the study failed to meet planned enrollment in the 2017-2018 cold season. The study was subsequently cancelled and enrollment was discontinued. Analysis of the 193 enrolled subjects was conducted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Sacavage, PharmD, Associate Director, Global Pain & Allergy Clinical Research
Organization: JNJWorldwide
Phone: 215 273-8568 ext 8568
EMail: ssacavag@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT03339726    
Other Study ID Numbers: CO-170302131230-URCT
First Submitted: November 8, 2017
First Posted: November 13, 2017
Results First Submitted: April 16, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019