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Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache

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ClinicalTrials.gov Identifier: NCT01842633
Recruitment Status : Terminated
First Posted : April 29, 2013
Results First Posted : July 27, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Paracetamol and Caffeine
Drug: Ibuprofen
Other: Placebo
Enrollment 365
Recruitment Details Participants were recruited at clinical sites in the United States.
Pre-assignment Details 365 participants were enrolled in the study out of which 165 participants were randomized in the study. 200 participants were not randomized for the following reasons: 165 were screening failure, 3 due to Adverse Events (AEs), 7 were lost to follow-up, 19 withdrawals by participant, and 6 due to other reasons.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description Participants were administered with two caplets of paracetamol/caffeine combination 500/65milligram (mg) plus 2 placebo caplets orally with 8 ounces of water Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water Participants were administered with four placebo caplets with 8 ounces of water
Period Title: Overall Study
Started 65 66 34
Completed 62 64 34
Not Completed 3 2 0
Reason Not Completed
Screen Failure             1             0             0
Adverse Event             1             1             0
Withdrawal by Subject             0             1             0
Technical issues             1             0             0
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets Total
Hide Arm/Group Description Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounces of water Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water Participants were administered with four placebo caplets orally with 8 ounces of water Total of all reporting groups
Overall Number of Baseline Participants 62 62 33 157
Hide Baseline Analysis Population Description
Demography data is available for 157 Participants only (safety Population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 62 participants 33 participants 157 participants
39.9  (11.39) 38.1  (13.13) 38.5  (12.65) 38.9  (12.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 33 participants 157 participants
Female
46
  74.2%
44
  71.0%
23
  69.7%
113
  72.0%
Male
16
  25.8%
18
  29.0%
10
  30.3%
44
  28.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 33 participants 157 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.6%
0
   0.0%
1
   3.0%
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   6.5%
6
   9.7%
4
  12.1%
14
   8.9%
White
56
  90.3%
55
  88.7%
28
  84.8%
139
  88.5%
More than one race
1
   1.6%
1
   1.6%
0
   0.0%
2
   1.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
Hide Description SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4". PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).
Time Frame Up to 4 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.13  (2.164) -5.78  (2.098) -5.86  (2.339)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paracetamol/ Caffeine Caplets, Placebo Caplets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-1.36 to 0.42
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours
Hide Description

SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.

The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).
Time Frame From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 1 hour (n=62, 61, 33) -0.64  (0.488) -0.56  (0.418) -0.57  (0.505)
At 2 hour (n=62, 61, 33) -2.21  (1.106) -2.02  (1.002) -2.04  (1.088)
At 3 hour (n=61, 62, 32) -4.09  (1.524) -3.86  (1.342) -3.97  (1.528)
3.Secondary Outcome
Title Number of Participants With Perceptible Pain Relief
Hide Description [Not Specified]
Time Frame Baseline up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Measure Type: Number
Unit of Measure: number of participants
number of participants 62 61 33
number of censored participants 0 1 0
4.Secondary Outcome
Title Time to Perceptible Headache Relief
Hide Description Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.
Time Frame Baseline up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Median (Full Range)
Unit of Measure: minutes (min.)
27.00
(6.0 to 140.3)
29.67
(8.7 to 240.0)
27.00
(4.0 to 156.7)
5.Secondary Outcome
Title Number of Participants With Meaningful Pain Relief
Hide Description [Not Specified]
Time Frame Baseline up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Measure Type: Number
Unit of Measure: number of participants
number of participants 61 60 32
number of censored participants 1 2 1
6.Secondary Outcome
Title Time to Meaningful Headache Relief
Hide Description Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.
Time Frame Baseline up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Median (Full Range)
Unit of Measure: min.
43.33
(11.7 to 240.0)
54.17
(16.7 to 240.0)
46.67
(12.5 to 240.0)
7.Secondary Outcome
Title Total Pain Relief (TOTPAR)
Hide Description TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.
Time Frame From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline-1 hour (62, 61, 33) 1.31  (0.922) 1.17  (0.801) 1.14  (0.864)
Baseline-2 hour (62, 61, 33) 4.28  (1.818) 4.05  (1.740) 3.82  (1.886)
Baseline-3 hour (61, 62, 33) 7.84  (2.337) 7.51  (2.250) 7.35  (2.463)
Baseline-4 hour (59, 59, 33) 11.57  (3.373) 11.05  (3.774) 10.47  (4.053)
8.Secondary Outcome
Title Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)
Hide Description SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.
Time Frame From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 1 hour (n=62, 61, 33) 0.67  (0.505) 0.61  (0.424) 0.57  (0.473)
At 2 hour (n=62, 61, 33) 2.07  (0.957) 2.03  (0.933) 1.78  (1.116)
At 3 hour (n=61, 62, 32) 3.75  (1.250) 3.64  (1.285) 3.38  (1.581)
At 4 hour (n=59, 59, 33) 5.44  (1.890) 5.28  (2.126) 4.61  (2.613)
9.Secondary Outcome
Title Global Evaluation of Response to Treatment
Hide Description Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral [neither poor nor good], 3-good, or 4-very good).
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.88  (0.740) 2.81  (0.834) 2.66  (0.946)
10.Secondary Outcome
Title Rate of Rescue Medication
Hide Description Number of participants that took rescue medication over the total number of participants for a given treatment group
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment, who took rescue medication and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Measure Type: Number
Unit of Measure: number of participants
2 4 4
11.Secondary Outcome
Title Change From Baseline in Headache Pain Intensity
Hide Description Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).
Time Frame At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 10 min. -0.03  (0.166) -0.01  (0.064) -0.04  (0.211)
At 15 min. -0.10  (0.322) -0.06  (0.208) -0.10  (0.366)
At 20 min. -0.27  (0.439) -0.21  (0.359) -0.21  (0.464)
At 25 min. -0.45  (0.501) -0.34  (0.438) -0.36  (0.582)
At 30 min. -0.66  (0.625) -0.51  (0.531) -0.55  (0.697)
At 40 min. -0.92  (0.727) -0.75  (0.618) -0.75  (0.729)
At 50 min. -1.07  (0.769) -0.93  (0.736) -0.96  (0.725)
At 60 min. -1.26  (0.831) -1.17  (0.751) -1.14  (0.706)
At 90 min. -1.51  (0.748) -1.48  (0.708) -1.39  (0.733)
At 120 min. -1.76  (0.704) -1.73  (0.727) -1.69  (0.725)
At 180 min. -1.95  (0.529) -1.90  (0.530) -1.93  (0.561)
At 240 min. -2.01  (0.575) -1.91  (0.609) -1.95  (0.591)
12.Secondary Outcome
Title Headache Relief
Hide Description The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.
Time Frame At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/ Caffiene Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
10 min. 0.07  (0.301) 0.03  (0.140) 0.11  (0.379)
15 min. 0.33  (0.660) 0.16  (0.374) 0.27  (0.635)
20 min. 0.68  (0.870) 0.49  (0.670) 0.60  (0.876)
25 min. 1.06  (1.059) 0.77  (0.870) 0.88  (0.986)
30 min. 1.37  (1.158) 1.17  (1.072) 1.22  (1.107)
40 min. 1.86  (1.341) 1.62  (1.195) 1.49  (1.182)
50 min. 2.15  (1.404) 1.91  (1.356) 1.82  (1.218)
60 min. 2.42  (1.380) 2.34  (1.255) 2.14  (1.213)
90 min. 2.85  (1.249) 2.91  (1.162) 2.68  (1.196)
120 min. 3.35  (0.962) 3.37  (1.113) 3.03  (1.206)
180 min. 3.69  (0.749) 3.59  (0.907) 3.44  (0.978)
240 min. 3.72  (0.795) 3.55  (1.138) 3.32  (1.155)
13.Secondary Outcome
Title Number of Pain Free Participants
Hide Description Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.
Time Frame 1 hour and 2 hour post dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol/Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Measure Type: Number
Unit of Measure: number of participants
At 1 hour 18 17 6
At 2 hour 38 41 20
14.Secondary Outcome
Title Time to the Use of Rescue Medication.
Hide Description Time taken by the participants to use the rescue medication
Time Frame Up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description:
Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
Participants were administered with four placebo caplets orally with eight ounce of water
Overall Number of Participants Analyzed 62 62 33
Mean (Standard Deviation)
Unit of Measure: Minutes
239.00  (6.86) 235.14  (24.06) 235.55  (12.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Hide Arm/Group Description Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounce of water Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounce of water Participants were administered with four placebo caplets orally with 8 ounce of water
All-Cause Mortality
Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/62 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Paracetamol/ Caffeine Caplets Ibuprofen Caplets Placebo Caplets
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/62 (6.45%)   3/62 (4.84%)   1/33 (3.03%) 
Endocrine disorders       
HYPOTHYROIDISM † 1  1/62 (1.61%)  0/62 (0.00%)  0/33 (0.00%) 
Gastrointestinal disorders       
Dyspepsia † 1  1/62 (1.61%)  0/62 (0.00%)  0/33 (0.00%) 
General disorders       
FEELING JITTERY † 1  1/62 (1.61%)  0/62 (0.00%)  0/33 (0.00%) 
Infections and infestations       
Nasopharyngitis † 1  1/62 (1.61%)  0/62 (0.00%)  0/33 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION † 1  1/62 (1.61%)  0/62 (0.00%)  0/33 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION † 1  0/62 (0.00%)  0/62 (0.00%)  1/33 (3.03%) 
Psychiatric disorders       
DEPRESSION † 1  0/62 (0.00%)  1/62 (1.61%)  0/33 (0.00%) 
INSOMNIA † 1  0/62 (0.00%)  1/62 (1.61%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
OROPHARYNGEAL PAIN † 1  0/62 (0.00%)  1/62 (1.61%)  0/33 (0.00%) 
PARANASAL SINUS DISCOMFORT † 1  0/62 (0.00%)  1/62 (1.61%)  0/33 (0.00%) 
SINUS CONGESTION † 1  0/62 (0.00%)  1/62 (1.61%)  0/33 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Enrollment into the trial was terminated after randomization of 62% of the plan resulting in a significant reduction in study power. The originally planned inferential statistics (p-values) were therefore not presented in tables summarizing results.
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01842633    
Other Study ID Numbers: 202172
RH01649 ( Other Identifier: GSK )
First Submitted: April 25, 2013
First Posted: April 29, 2013
Results First Submitted: June 2, 2016
Results First Posted: July 27, 2017
Last Update Posted: September 1, 2017