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:
Johnson & Johnson Consumer Inc. (J&JCI)
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | PE-IR | PE-ER |
---|---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | Placebo | PE-IR | PE-ER | Total | |
---|---|---|---|---|---|
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 | |
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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
Results Point of Contact
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 |
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 |