Trial Outcomes & Findings for A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine (NCT NCT02863575)
NCT ID: NCT02863575
Last Updated: 2019-04-08
Results Overview
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.
COMPLETED
PHASE3
374 participants
From 0 to 8 hours post-dose on Day 1
2019-04-08
Participant Flow
Participant milestones
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
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.
|
Ibuprofen 400 mg
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.
|
Placebo
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 Study
STARTED
|
161
|
161
|
52
|
|
Overall Study
COMPLETED
|
160
|
159
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
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.
|
Ibuprofen 400 mg
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.
|
Placebo
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 Study
Participants Unable To Swallow Capsule
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Baseline characteristics by cohort
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.3 years
STANDARD_DEVIATION 3.03 • n=99 Participants
|
19.1 years
STANDARD_DEVIATION 2.88 • n=107 Participants
|
18.9 years
STANDARD_DEVIATION 2.93 • n=206 Participants
|
19.1 years
STANDARD_DEVIATION 2.95 • n=157 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
196 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
178 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
321 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
White
|
153 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
346 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: From 0 to 8 hours post-dose on Day 1Population: Full analysis set (FAS) population included all randomized participants who received study medication and provided a baseline assessment.
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.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
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.
|
|---|---|---|---|
|
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
|
55.5 units on a scale
Standard Error 1.8
|
52.8 units on a scale
Standard Error 1.8
|
—
|
SECONDARY outcome
Timeframe: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
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.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
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)
SPRID 0-2
|
13.3 units on a scale
Standard Error 0.4
|
12.2 units on a scale
Standard Error 0.4
|
2.2 units on a scale
Standard Error 0.7
|
|
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)
SPRID 0-4
|
30.0 units on a scale
Standard Error 0.8
|
28.5 units on a scale
Standard Error 0.8
|
6.0 units on a scale
Standard Error 1.5
|
|
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)
SPRID 0-6
|
44.5 units on a scale
Standard Error 1.3
|
42.1 units on a scale
Standard Error 1.3
|
10.2 units on a scale
Standard Error 2.3
|
|
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)
SPRID 0-8
|
55.5 units on a scale
Standard Error 1.8
|
52.8 units on a scale
Standard Error 1.8
|
14.6 units on a scale
Standard Error 3.3
|
SECONDARY outcome
Timeframe: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
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.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
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)
SPID 0-2
|
8.7 units on a scale
Standard Error 0.3
|
8.0 units on a scale
Standard Error 0.3
|
1.2 units on a scale
Standard Error 0.5
|
|
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)
SPID 0-4
|
19.9 units on a scale
Standard Error 0.6
|
18.8 units on a scale
Standard Error 0.6
|
3.5 units on a scale
Standard Error 1.0
|
|
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)
SPID 0-6
|
29.5 units on a scale
Standard Error 0.9
|
27.7 units on a scale
Standard Error 0.9
|
6.1 units on a scale
Standard Error 1.6
|
|
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)
SPID 0-8
|
36.6 units on a scale
Standard Error 1.3
|
34.6 units on a scale
Standard Error 1.3
|
8.8 units on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
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.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
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)
TOTPAR 0-6
|
15.0 units on a scale
Standard Error 0.4
|
14.4 units on a scale
Standard Error 0.4
|
4.1 units on a scale
Standard Error 0.7
|
|
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)
TOTPAR 0-8
|
18.8 units on a scale
Standard Error 0.6
|
18.2 units on a scale
Standard Error 0.6
|
5.8 units on a scale
Standard Error 1.0
|
|
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)
TOTPAR 0-2
|
4.6 units on a scale
Standard Error 0.1
|
4.2 units on a scale
Standard Error 0.1
|
1.0 units on a scale
Standard Error 0.2
|
|
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)
TOTPAR 0-4
|
10.2 units on a scale
Standard Error 0.3
|
9.7 units on a scale
Standard Error 0.3
|
2.5 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
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.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
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
0.25 hour
|
0.8 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.2
|
|
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
0.5 hour
|
3.3 units on a scale
Standard Error 0.2
|
3.3 units on a scale
Standard Error 0.2
|
1.0 units on a scale
Standard Error 0.4
|
|
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
1 hour
|
7.2 units on a scale
Standard Error 0.2
|
6.5 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.4
|
|
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
1.5 hour
|
8.5 units on a scale
Standard Error 0.2
|
7.7 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.4
|
|
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
2 hour
|
8.9 units on a scale
Standard Error 0.2
|
8.3 units on a scale
Standard Error 0.2
|
1.3 units on a scale
Standard Error 0.4
|
|
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
3 hour
|
8.7 units on a scale
Standard Error 0.2
|
8.3 units on a scale
Standard Error 0.2
|
1.8 units on a scale
Standard Error 0.4
|
|
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
4 hour
|
8.1 units on a scale
Standard Error 0.3
|
8.0 units on a scale
Standard Error 0.3
|
2.0 units on a scale
Standard Error 0.5
|
|
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
5 hour
|
7.6 units on a scale
Standard Error 0.3
|
7.3 units on a scale
Standard Error 0.3
|
2.1 units on a scale
Standard Error 0.5
|
|
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
6 hour
|
6.9 units on a scale
Standard Error 0.3
|
6.4 units on a scale
Standard Error 0.3
|
2.1 units on a scale
Standard Error 0.5
|
|
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
7 hour
|
5.7 units on a scale
Standard Error 0.3
|
5.6 units on a scale
Standard Error 0.3
|
2.2 units on a scale
Standard Error 0.6
|
|
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
8 hour
|
5.2 units on a scale
Standard Error 0.3
|
5.0 units on a scale
Standard Error 0.3
|
2.2 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
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.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
0.25 hour
|
0.4 units on a scale
Standard Error 0.0
|
0.4 units on a scale
Standard Error 0.0
|
0.3 units on a scale
Standard Error 0.1
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
0.5 hour
|
1.3 units on a scale
Standard Error 0.1
|
1.2 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
1 hour
|
2.5 units on a scale
Standard Error 0.1
|
2.3 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
1.5 hour
|
2.8 units on a scale
Standard Error 0.1
|
2.6 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
2 hour
|
3.0 units on a scale
Standard Error 0.1
|
2.8 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.1
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
3 hour
|
2.9 units on a scale
Standard Error 0.1
|
2.8 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.1
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
4 hour
|
2.7 units on a scale
Standard Error 0.1
|
2.7 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.1
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
5 hour
|
2.6 units on a scale
Standard Error 0.1
|
2.5 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.2
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
6 hour
|
2.3 units on a scale
Standard Error 0.1
|
2.2 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.2
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
7 hour
|
2.0 units on a scale
Standard Error 0.1
|
2.0 units on a scale
Standard Error 0.1
|
0.9 units on a scale
Standard Error 0.2
|
|
Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
8 hour
|
1.8 units on a scale
Standard Error 0.1
|
1.8 units on a scale
Standard Error 0.1
|
0.9 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
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.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
8 hour
|
3.4 units on a scale
Standard Error 0.2
|
3.3 units on a scale
Standard Error 0.2
|
1.3 units on a scale
Standard Error 0.4
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
0.25 hour
|
0.4 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
0.4 units on a scale
Standard Error 0.2
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
0.5 hour
|
2.0 units on a scale
Standard Error 0.2
|
2.1 units on a scale
Standard Error 0.2
|
0.6 units on a scale
Standard Error 0.3
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
1 hour
|
4.7 units on a scale
Standard Error 0.2
|
4.2 units on a scale
Standard Error 0.2
|
0.6 units on a scale
Standard Error 0.3
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
1.5 hour
|
5.6 units on a scale
Standard Error 0.2
|
5.1 units on a scale
Standard Error 0.2
|
0.6 units on a scale
Standard Error 0.3
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
2 hour
|
5.9 units on a scale
Standard Error 0.2
|
5.5 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.3
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
3 hour
|
5.8 units on a scale
Standard Error 0.2
|
5.5 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.3
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
4 hour
|
5.4 units on a scale
Standard Error 0.2
|
5.3 units on a scale
Standard Error 0.2
|
1.2 units on a scale
Standard Error 0.3
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
5 hour
|
5.0 units on a scale
Standard Error 0.2
|
4.8 units on a scale
Standard Error 0.2
|
1.3 units on a scale
Standard Error 0.3
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
6 hour
|
4.5 units on a scale
Standard Error 0.2
|
4.1 units on a scale
Standard Error 0.2
|
1.2 units on a scale
Standard Error 0.4
|
|
Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose
7 hour
|
3.8 units on a scale
Standard Error 0.2
|
3.6 units on a scale
Standard Error 0.2
|
1.3 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Up to 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "meaningful relief" at the moment when they first experienced meaningful relief, that is, when the relief from the pain was meaningful to them. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered).
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Time to Onset of Achieving Meaningful Relief
|
46.60 minutes
Interval 42.82 to 49.15
|
52.25 minutes
Interval 49.15 to 59.18
|
NA minutes
Due to smaller number of participants with an event, median and 95% CI could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 8 hours post-dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "first perceptible relief" at the moment when they first began to feel any pain relieving effect. It was when they first felt a little/noticeable pain relief. It did not mean that they felt completely better (though they might), but when they first felt any difference in pain that they had at present. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered).
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Time to Onset of First Perceptible Relief
|
25.80 minutes
Interval 21.93 to 29.42
|
24.52 minutes
Interval 22.78 to 26.9
|
NA minutes
Due to smaller number of participants with an event, median and 95% CI could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 8 hours post dose on Day 1Population: FAS population included all randomized participants who received study medication and provided a baseline assessment.
Treatment failure was defined as time to first dose of rescue medication or study discontinuation of the participants due to lack of efficacy.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Time to Treatment Failure
|
NA minutes
Due to smaller number of participants with an event, median and 95% CI could not be calculated.
|
NA minutes
Due to smaller number of participants with an event, median and 95% CI could not be calculated.
|
310.00 minutes
Interval 132.0 to 480.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)Population: Safety analysis population included all participants who received the study medication. Here, "Overall Number of Participants Analyzed" were those participants who had at least 1 treatment emergent AEs.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs are classified according to severity in 3 categories as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=15 Participants
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.
|
Ibuprofen 400 mg
n=15 Participants
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.
|
Placebo
n=8 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Mild
|
3 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Moderate
|
12 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)Population: Safety analysis population included all participants who received the study medication. Here, "Overall Number of Participants Analyzed" were those participants who had at least 1 treatment emergent AEs.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. Relatedness of an AE to study drug was assessed by investigator.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=15 Participants
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.
|
Ibuprofen 400 mg
n=15 Participants
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.
|
Placebo
n=8 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Treatment Related Adverse Events (AEs)
|
1 Participants
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)Population: Safety analysis population included all participants who received the study medication.
Vital signs included: heart rate, blood pressure, respiratory rate, and temperature. Normal range for the vital signs were: systolic blood pressure 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure 60 to 90 mmHg, heart rate 50 to 110 beats per minute, respiratory rate 12 to 22 breaths per minute, and oral temperature 97.0 to 99.6 Fahrenheit (F). Value for vital signs outside the normal range was consider as abnormal. Clinical significance of vital signs abnormalities was determined at the investigator's discretion.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: Safety analysis population included all participants who received the study medication.
Rescue medication: participants who did not experience adequate relief after the 1 hour (post study drug dose) evaluation were given tramadol hydrochloride 50 to 100 mg orally or codeine sulfate 15 to 60 mg orally, based on the discretion of the Investigator, as rescue medication. If needed, 2 additional doses of rescue medications based on the discretion of the Investigator at the study center was given. Total maximum dose of tramadol was 300 mg and of codeine sulfate was 180 mg. Concomitant medication: medication received by participant other than study medication and rescue medication.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Used Concomitant Medications, and Rescue Medications
Concomitant Medications
|
25 Participants
|
39 Participants
|
11 Participants
|
|
Number of Participants Who Used Concomitant Medications, and Rescue Medications
Rescue Medications
|
29 Participants
|
25 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At ScreeningPopulation: Safety analysis population included all participants who received the study medication.
In this outcome measure number of participants who were using any type of medications, prior to start of the study were reported.
Outcome measures
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 Participants
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.
|
Ibuprofen 400 mg
n=161 Participants
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.
|
Placebo
n=52 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Used Medications Prior to This Study
|
161 Participants
|
161 Participants
|
52 Participants
|
Adverse Events
Ibuprofen 400 mg + Caffeine 100 mg
Ibuprofen 400 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibuprofen 400 mg + Caffeine 100 mg
n=161 participants at risk
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.
|
Ibuprofen 400 mg
n=161 participants at risk
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.
|
Placebo
n=52 participants at risk
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.
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
4/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
2.5%
4/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
13.5%
7/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
General disorders
Pain
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Osteomyelitis
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
1.2%
2/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
1.9%
1/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
1.2%
2/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Viral infection
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
1.9%
1/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Investigations
Blood bilirubin increased
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Investigations
Weight decreased
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Psychiatric disorders
Anxiety
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Psychiatric disorders
Mood swings
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.62%
1/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
3/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
1.2%
2/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
11.5%
6/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
|
Infections and infestations
Alveolar osteitis
|
1.2%
2/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/161 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
0.00%
0/52 • Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results
- Publication restrictions are in place
Restriction type: OTHER