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A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine

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: NCT02863575
Recruitment Status : Completed
First Posted : August 11, 2016
Results First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Ibuprofen/Caffeine
Drug: Ibuprofen
Drug: Placebo
Enrollment 374
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo
Hide Arm/Group Description Participants were randomized to receive a single oral dose of ibuprofen 400 milligram (mg) with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug. Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug. Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Period Title: Overall Study
Started 161 161 52
Completed 160 159 51
Not Completed 1 2 1
Reason Not Completed
Participants Unable To Swallow Capsule             1             0             0
Withdrawal by Subject             0             1             1
Adverse Event             0             1             0
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo Total
Hide Arm/Group Description Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug. Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug. Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug. Total of all reporting groups
Overall Number of Baseline Participants 161 161 52 374
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 161 participants 52 participants 374 participants
19.3  (3.03) 19.1  (2.88) 18.9  (2.93) 19.1  (2.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 161 participants 52 participants 374 participants
Female
85
  52.8%
84
  52.2%
27
  51.9%
196
  52.4%
Male
76
  47.2%
77
  47.8%
25
  48.1%
178
  47.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 161 participants 52 participants 374 participants
Hispanic or Latino
19
  11.8%
26
  16.1%
8
  15.4%
53
  14.2%
Not Hispanic or Latino
142
  88.2%
135
  83.9%
44
  84.6%
321
  85.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 161 participants 52 participants 374 participants
White
153
  95.0%
142
  88.2%
51
  98.1%
346
  92.5%
Asian
2
   1.2%
3
   1.9%
0
   0.0%
5
   1.3%
Black or African American
2
   1.2%
2
   1.2%
0
   0.0%
4
   1.1%
American Indian or Alaska Native
1
   0.6%
1
   0.6%
0
   0.0%
2
   0.5%
Native Hawaiian or Other Pacific Islander
1
   0.6%
7
   4.3%
0
   0.0%
8
   2.1%
Other
2
   1.2%
6
   3.7%
1
   1.9%
9
   2.4%
1.Primary Outcome
Title Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen
Hide Description SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question “How much relief do you have from your starting pain?” on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question “How much pain do you have at this time?” on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain.
Time Frame From 0 to 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all randomized participants who received study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Overall Number of Participants Analyzed 161 161
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
55.5  (1.8) 52.8  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) means difference
Estimated Value 2.68
Confidence Interval (2-Sided) 95%
-2.46 to 7.82
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8)
Hide Description SPRID 0-2, SPRID 0-4, SPRID 0-6, SPRID 0-8: time-weighted sum of PRID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours respectively. PRID at each post-dose time point = PID + PRR. PRR score: at each post-dose time point participants answered to question “How much relief do you have from your starting pain?” on 5-point scale: 0=none, 1=a little, 2=some, 3=a lot, 4=complete; higher scores=more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to question “How much pain do you have at this time?” on 11-point scale: range from 0=no pain to 10=worst possible pain; higher scores=worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value=greater improvement. Score range for: SPRID 0-2= -20 to 28; SPRID 0-4= -40 to 56; SPRID 0-6= -60 to 84; SPRID 0-8= -80 to 112. Higher SPRID scores=more improvement in pain.
Time Frame From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Overall Number of Participants Analyzed 161 161 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
SPRID 0-2 13.3  (0.4) 12.2  (0.4) 2.2  (0.7)
SPRID 0-4 30.0  (0.8) 28.5  (0.8) 6.0  (1.5)
SPRID 0-6 44.5  (1.3) 42.1  (1.3) 10.2  (2.3)
SPRID 0-8 55.5  (1.8) 52.8  (1.8) 14.6  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments SPRID 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
-0.03 to 2.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPRID 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 11.13
Confidence Interval (2-Sided) 95%
9.54 to 12.73
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPRID 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 10.05
Confidence Interval (2-Sided) 95%
8.45 to 11.64
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments SPRID 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
-0.72 to 3.87
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPRID 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 24.04
Confidence Interval (2-Sided) 95%
20.76 to 27.32
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPRID 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 22.46
Confidence Interval (2-Sided) 95%
19.18 to 25.75
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments SPRID 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.201
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.39
Confidence Interval (2-Sided) 95%
-1.28 to 6.06
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPRID 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 34.30
Confidence Interval (2-Sided) 95%
29.06 to 39.55
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPRID 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 31.91
Confidence Interval (2-Sided) 95%
26.67 to 37.16
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPRID 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 40.85
Confidence Interval (2-Sided) 95%
33.49 to 48.20
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPRID 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 38.17
Confidence Interval (2-Sided) 95%
30.81 to 45.52
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8)
Hide Description SPID 0-2, SPID 0-4, SPID 0-6, SPID 0-8: time-weighted sum of PID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. NPSR scale: at baseline and each post-dose time point participants answered to question “How much pain do you have at this time?” on an 11-point scale: score range from 0 = no pain to 10 = worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible range: SPID 0-2 = -20 to 20; SPID 0-4 = -40 to 40; SPID 0-6 = -60 to 60; SPID 0-8 = -80 to 80. Higher SPID scores = more improvement in pain.
Time Frame From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Overall Number of Participants Analyzed 161 161 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
SPID 0-2 8.7  (0.3) 8.0  (0.3) 1.2  (0.5)
SPID 0-4 19.9  (0.6) 18.8  (0.6) 3.5  (1.0)
SPID 0-6 29.5  (0.9) 27.7  (0.9) 6.1  (1.6)
SPID 0-8 36.6  (1.3) 34.6  (1.3) 8.8  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments SPID 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
-0.05 to 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPID 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 7.55
Confidence Interval (2-Sided) 95%
6.44 to 8.66
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPID 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.82
Confidence Interval (2-Sided) 95%
5.71 to 7.93
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments SPID 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
-0.47 to 2.74
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPID 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 16.35
Confidence Interval (2-Sided) 95%
14.05 to 18.64
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPID 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 15.21
Confidence Interval (2-Sided) 95%
12.91 to 17.51
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments SPID 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
-0.78 to 4.34
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPID 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 23.37
Confidence Interval (2-Sided) 95%
19.71 to 27.03
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPID 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 21.59
Confidence Interval (2-Sided) 95%
17.93 to 25.25
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments SPID 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.10
Confidence Interval (2-Sided) 95%
-1.47 to 5.67
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments SPID 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 27.88
Confidence Interval (2-Sided) 95%
22.78 to 32.99
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments SPID 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 25.79
Confidence Interval (2-Sided) 95%
20.68 to 30.89
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8)
Hide Description TOTPAR 0-2, TOTPAR 0-4, TOTPAR 0-6, TOTPAR 0-8: time-weighted sum of PRR scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. PRR score: at each post-dose time point participants answered to the question “How much relief do you have from your starting pain?” on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Overall possible range: TOTPAR 0-2 = 0 to 8; TOTPAR 0-4 = 0 to 16; TOTPAR 0-6 = 0 to 24; TOTPAR 0-8 = 0 to 32. Higher TOTPAR scores = more improvement in pain.
Time Frame From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Overall Number of Participants Analyzed 161 161 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
TOTPAR 0-2 4.6  (0.1) 4.2  (0.1) 1.0  (0.2)
TOTPAR 0-4 10.2  (0.3) 9.7  (0.3) 2.5  (0.5)
TOTPAR 0-6 15.0  (0.4) 14.4  (0.4) 4.1  (0.7)
TOTPAR 0-8 18.8  (0.6) 18.2  (0.6) 5.8  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments TOTPAR 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.01 to 0.71
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments TOTPAR 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.59
Confidence Interval (2-Sided) 95%
3.09 to 4.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments TOTPAR 0-2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.23
Confidence Interval (2-Sided) 95%
2.73 to 3.73
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments TOTPAR 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.224
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
-0.27 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments TOTPAR 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 7.69
Confidence Interval (2-Sided) 95%
6.68 to 8.71
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments TOTPAR 0-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 7.25
Confidence Interval (2-Sided) 95%
6.23 to 8.27
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments TOTPAR 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.293
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
-0.53 to 1.75
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments TOTPAR 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 10.93
Confidence Interval (2-Sided) 95%
9.30 to 12.56
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments TOTPAR 0-6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 10.32
Confidence Interval (2-Sided) 95%
8.69 to 11.95
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments TOTPAR 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
-1.03 to 2.19
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments TOTPAR 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 12.96
Confidence Interval (2-Sided) 95%
10.66 to 15.26
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments TOTPAR 0-8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 12.38
Confidence Interval (2-Sided) 95%
10.08 to 14.68
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
Hide Description PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to a question “How much relief do you have from your starting pain?” on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to a question “How much pain do you have at this time?” on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. At a single post-dose time point overall possible range for PRID score: -10 to 14, higher scores = more improvement in pain.
Time Frame 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Overall Number of Participants Analyzed 161 161 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.25 hour 0.8  (0.1) 0.8  (0.1) 0.7  (0.2)
0.5 hour 3.3  (0.2) 3.3  (0.2) 1.0  (0.4)
1 hour 7.2  (0.2) 6.5  (0.2) 1.1  (0.4)
1.5 hour 8.5  (0.2) 7.7  (0.2) 1.1  (0.4)
2 hour 8.9  (0.2) 8.3  (0.2) 1.3  (0.4)
3 hour 8.7  (0.2) 8.3  (0.2) 1.8  (0.4)
4 hour 8.1  (0.3) 8.0  (0.3) 2.0  (0.5)
5 hour 7.6  (0.3) 7.3  (0.3) 2.1  (0.5)
6 hour 6.9  (0.3) 6.4  (0.3) 2.1  (0.5)
7 hour 5.7  (0.3) 5.6  (0.3) 2.2  (0.6)
8 hour 5.2  (0.3) 5.0  (0.3) 2.2  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.975
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.35 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.40 to 0.63
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.40 to 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.70 to 0.63
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.26
Confidence Interval (2-Sided) 95%
1.31 to 3.20
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.29
Confidence Interval (2-Sided) 95%
1.35 to 3.24
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.04 to 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.11
Confidence Interval (2-Sided) 95%
5.12 to 7.10
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 5.38
Confidence Interval (2-Sided) 95%
4.39 to 6.37
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.16 to 1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 7.36
Confidence Interval (2-Sided) 95%
6.39 to 8.33
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.52
Confidence Interval (2-Sided) 95%
5.55 to 7.49
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
-0.05 to 1.30
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 7.62
Confidence Interval (2-Sided) 95%
6.65 to 8.58
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.99
Confidence Interval (2-Sided) 95%
6.03 to 7.96
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-0.28 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.83
Confidence Interval (2-Sided) 95%
5.85 to 7.80
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.42
Confidence Interval (2-Sided) 95%
5.44 to 7.40
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.65 to 0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.08
Confidence Interval (2-Sided) 95%
5.02 to 7.14
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 6.00
Confidence Interval (2-Sided) 95%
4.94 to 7.05
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.438
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-0.48 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 5.47
Confidence Interval (2-Sided) 95%
4.33 to 6.60
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 5.15
Confidence Interval (2-Sided) 95%
4.01 to 6.29
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 6 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
-0.35 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 6 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.80
Confidence Interval (2-Sided) 95%
3.58 to 6.02
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 6 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.30
Confidence Interval (2-Sided) 95%
3.08 to 5.52
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 7 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.818
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.80 to 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 7 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.53
Confidence Interval (2-Sided) 95%
2.23 to 4.82
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 7 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.42
Confidence Interval (2-Sided) 95%
2.12 to 4.71
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRID at 8 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.74 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRID at 8 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.02
Confidence Interval (2-Sided) 95%
1.69 to 4.34
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRID at 8 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.83
Confidence Interval (2-Sided) 95%
1.51 to 4.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
Hide Description PRR score: at each post-dose time point participants answered to a question “How much relief do you have from your starting pain?” on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain.
Time Frame 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Overall Number of Participants Analyzed 161 161 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.25 hour 0.4  (0.0) 0.4  (0.0) 0.3  (0.1)
0.5 hour 1.3  (0.1) 1.2  (0.1) 0.5  (0.1)
1 hour 2.5  (0.1) 2.3  (0.1) 0.5  (0.1)
1.5 hour 2.8  (0.1) 2.6  (0.1) 0.5  (0.1)
2 hour 3.0  (0.1) 2.8  (0.1) 0.6  (0.1)
3 hour 2.9  (0.1) 2.8  (0.1) 0.7  (0.1)
4 hour 2.7  (0.1) 2.7  (0.1) 0.8  (0.1)
5 hour 2.6  (0.1) 2.5  (0.1) 0.8  (0.2)
6 hour 2.3  (0.1) 2.2  (0.1) 0.8  (0.2)
7 hour 2.0  (0.1) 2.0  (0.1) 0.9  (0.2)
8 hour 1.8  (0.1) 1.8  (0.1) 0.9  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.04
Confidence Interval (2-Sided) 94%
-0.09 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.11 to 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.686
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.14 to 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.15 to 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.49 to 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.42 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.01 to 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.01
Confidence Interval (2-Sided) 95%
1.69 to 2.33
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
1.46 to 2.09
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.03 to 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.33
Confidence Interval (2-Sided) 95%
2.02 to 2.64
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.08
Confidence Interval (2-Sided) 95%
1.77 to 2.39
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.04 to 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.40
Confidence Interval (2-Sided) 95%
2.09 to 2.71
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
1.91 to 2.53
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.13 to 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.16
Confidence Interval (2-Sided) 95%
1.86 to 2.47
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.08
Confidence Interval (2-Sided) 95%
1.78 to 2.38
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.23 to 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.94
Confidence Interval (2-Sided) 95%
1.61 to 2.28
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.94
Confidence Interval (2-Sided) 95%
1.61 to 2.28
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.19 to 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.73
Confidence Interval (2-Sided) 95%
1.36 to 2.09
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
1.31 to 2.03
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 6 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.425
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.11
Confidence Interval (2-Sided) 94%
-0.16 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 6 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.12 to 1.90
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 6 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
1.01 to 1.79
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 7 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.32 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 7 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.69 to 1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 7 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.72 to 1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PRR score at 8 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.980
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.00
Confidence Interval 95%
-0.30 to 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PRR score at 8 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.50 to 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PRR score at 8 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.50 to 1.35
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
Hide Description NPSR scale: at baseline and each post-dose time point participants answered to a question “How much pain do you have at this time?” on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a single post-dose time point: -10 to 10, higher positive value = greater improvement in pain.
Time Frame 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen 400 mg + Caffeine 100 mg Ibuprofen 400 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Overall Number of Participants Analyzed 161 161 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.25 hour 0.4  (0.1) 0.5  (0.1) 0.4  (0.2)
0.5 hour 2.0  (0.2) 2.1  (0.2) 0.6  (0.3)
1 hour 4.7  (0.2) 4.2  (0.2) 0.6  (0.3)
1.5 hour 5.6  (0.2) 5.1  (0.2) 0.6  (0.3)
2 hour 5.9  (0.2) 5.5  (0.2) 0.7  (0.3)
3 hour 5.8  (0.2) 5.5  (0.2) 1.1  (0.3)
4 hour 5.4  (0.2) 5.3  (0.2) 1.2  (0.3)
5 hour 5.0  (0.2) 4.8  (0.2) 1.3  (0.3)
6 hour 4.5  (0.2) 4.1  (0.2) 1.2  (0.4)
7 hour 3.8  (0.2) 3.6  (0.2) 1.3  (0.4)
8 hour 3.4  (0.2) 3.3  (0.2) 1.3  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.27 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 0.25 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.804
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.30 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 0.25 hr
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.27 to 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.55 to 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.81 to 2.10
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 0.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
0.91 to 2.20
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.01 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.10
Confidence Interval 95%
3.41 to 4.78
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.60
Confidence Interval (2-Sided) 95%
2.92 to 4.29
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.11 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 5.03
Confidence Interval (2-Sided) 95%
4.35 to 5.71
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 1.5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.44
Confidence Interval (2-Sided) 95%
3.76 to 5.12
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
-0.03 to 0.91
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 5.22
Confidence Interval (2-Sided) 95%
4.54 to 5.89
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 2 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.78
Confidence Interval (2-Sided) 95%
4.10 to 5.45
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
-0.16 to 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.66
Confidence Interval (2-Sided) 95%
3.98 to 5.35
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 3 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.34
Confidence Interval (2-Sided) 95%
3.65 to 5.03
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.750
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.43 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.14
Confidence Interval (2-Sided) 95%
3.40 to 4.87
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 4 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 4.05
Confidence Interval (2-Sided) 95%
3.32 to 4.79
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Ibuprofen 400 mg
Comments PID score at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
-0.30 to 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg + Caffeine 100 mg, Placebo
Comments PID score at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.74
Confidence Interval (2-Sided) 95%
2.95 to 4.53
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400 mg, Placebo
Comments PID score at 5 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter