Trial Outcomes & Findings for Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain (NCT NCT01559259)
NCT ID: NCT01559259
Last Updated: 2020-05-19
Results Overview
SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
394 participants
Primary outcome timeframe
From 0 hour up to 8 hours post-dose
Results posted on
2020-05-19
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
90
|
93
|
89
|
92
|
|
Overall Study
COMPLETED
|
30
|
89
|
92
|
88
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
Total
n=394 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
18.3 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
17.7 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
18.4 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
17.8 years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
18.4 years
STANDARD_DEVIATION 1.9 • n=21 Participants
|
18.1 years
STANDARD_DEVIATION 2.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
200 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
194 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From 0 hour up to 8 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
|
5.0 units on a scale
Standard Deviation 13.2
|
30.8 units on a scale
Standard Deviation 12.7
|
29.6 units on a scale
Standard Deviation 15.6
|
31.7 units on a scale
Standard Deviation 14.6
|
28.8 units on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: From 0 hour up to 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time to Onset of Meaningful Pain Relief
|
NA minutes
Median was not analysed as median time to meaningful relief was greater than (\>) 720 minutes/12 hours) for placebo group and therefore 95% CI was not estimable.
|
44.5 minutes
Interval 37.0 to 55.0
|
54.1 minutes
Interval 44.7 to 73.6
|
45.9 minutes
Interval 42.2 to 57.2
|
56.2 minutes
Interval 52.0 to 77.0
|
SECONDARY outcome
Timeframe: From 0 hour up to 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure (defined as participant taking rescue medication, or discontinuing due to lack of efficacy) prior to depressing the first stopwatch or until the time of withdrawal (discontinuation).
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time to Confirmed First Perceptible Relief
|
NA minutes
Median was not analysed as median time to confirmed first perceptible relief was \>720 minutes (\>12 hours) for placebo group and therefore 95% CI was not estimable.
|
18.5 minutes
Interval 15.7 to 23.0
|
22.8 minutes
Interval 19.9 to 27.4
|
18.5 minutes
Interval 15.7 to 21.8
|
24.9 minutes
Interval 21.6 to 28.7
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participants answered a question: "how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Pain Relief Rating Score (PRR)
0.25 hour
|
0.2 units on a scale
Standard Deviation 0.4
|
0.6 units on a scale
Standard Deviation 0.8
|
0.5 units on a scale
Standard Deviation 0.8
|
0.7 units on a scale
Standard Deviation 0.9
|
0.4 units on a scale
Standard Deviation 0.6
|
|
Pain Relief Rating Score (PRR)
0.5 hour
|
0.3 units on a scale
Standard Deviation 0.5
|
1.7 units on a scale
Standard Deviation 1.0
|
1.5 units on a scale
Standard Deviation 1.2
|
1.6 units on a scale
Standard Deviation 1.1
|
1.1 units on a scale
Standard Deviation 0.9
|
|
Pain Relief Rating Score (PRR)
1 hour
|
0.4 units on a scale
Standard Deviation 0.6
|
2.5 units on a scale
Standard Deviation 1.1
|
2.3 units on a scale
Standard Deviation 1.1
|
2.5 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.1
|
|
Pain Relief Rating Score (PRR)
1.5 hour
|
0.4 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 0.9
|
2.6 units on a scale
Standard Deviation 1.1
|
2.8 units on a scale
Standard Deviation 1.0
|
2.5 units on a scale
Standard Deviation 1.2
|
|
Pain Relief Rating Score (PRR)
2 hour
|
0.4 units on a scale
Standard Deviation 0.8
|
2.9 units on a scale
Standard Deviation 1.0
|
2.7 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.1
|
2.6 units on a scale
Standard Deviation 1.3
|
|
Pain Relief Rating Score (PRR)
3 hour
|
0.5 units on a scale
Standard Deviation 1.0
|
2.9 units on a scale
Standard Deviation 1.0
|
2.8 units on a scale
Standard Deviation 1.2
|
3.0 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 1.3
|
|
Pain Relief Rating Score (PRR)
4 hour
|
0.5 units on a scale
Standard Deviation 1.1
|
2.9 units on a scale
Standard Deviation 1.0
|
2.7 units on a scale
Standard Deviation 1.3
|
2.9 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 1.4
|
|
Pain Relief Rating Score (PRR)
5 hour
|
0.5 units on a scale
Standard Deviation 1.1
|
2.7 units on a scale
Standard Deviation 1.1
|
2.6 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.4
|
|
Pain Relief Rating Score (PRR)
6 hour
|
0.6 units on a scale
Standard Deviation 1.2
|
2.5 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.4
|
2.7 units on a scale
Standard Deviation 1.4
|
2.4 units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating Score (PRR)
7 hour
|
0.6 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 1.4
|
2.3 units on a scale
Standard Deviation 1.4
|
2.1 units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating Score (PRR)
8 hour
|
0.6 units on a scale
Standard Deviation 1.2
|
1.7 units on a scale
Standard Deviation 1.5
|
1.9 units on a scale
Standard Deviation 1.4
|
1.9 units on a scale
Standard Deviation 1.5
|
1.9 units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating Score (PRR)
9 hour
|
0.6 units on a scale
Standard Deviation 1.2
|
1.4 units on a scale
Standard Deviation 1.5
|
1.5 units on a scale
Standard Deviation 1.4
|
1.7 units on a scale
Standard Deviation 1.5
|
1.7 units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating Score (PRR)
10 hour
|
0.6 units on a scale
Standard Deviation 1.2
|
1.2 units on a scale
Standard Deviation 1.4
|
1.2 units on a scale
Standard Deviation 1.3
|
1.5 units on a scale
Standard Deviation 1.5
|
1.4 units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating Score (PRR)
11 hour
|
0.6 units on a scale
Standard Deviation 1.3
|
0.9 units on a scale
Standard Deviation 1.4
|
1.0 units on a scale
Standard Deviation 1.3
|
1.3 units on a scale
Standard Deviation 1.4
|
1.3 units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating Score (PRR)
12 hour
|
0.6 units on a scale
Standard Deviation 1.3
|
0.8 units on a scale
Standard Deviation 1.3
|
0.9 units on a scale
Standard Deviation 1.2
|
1.1 units on a scale
Standard Deviation 1.3
|
1.2 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[no pain\] to 3 \[worst possible pain\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
0.25 hour
|
0.1 units on a scale
Standard Deviation 0.3
|
0.3 units on a scale
Standard Deviation 0.6
|
0.2 units on a scale
Standard Deviation 0.4
|
0.3 units on a scale
Standard Deviation 0.6
|
0.2 units on a scale
Standard Deviation 0.4
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
0.5 hour
|
0.1 units on a scale
Standard Deviation 0.4
|
0.9 units on a scale
Standard Deviation 0.8
|
0.7 units on a scale
Standard Deviation 0.8
|
0.8 units on a scale
Standard Deviation 0.8
|
0.5 units on a scale
Standard Deviation 0.7
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
1 hour
|
0.1 units on a scale
Standard Deviation 0.6
|
1.5 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 0.8
|
1.4 units on a scale
Standard Deviation 0.9
|
1.1 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
1.5 hour
|
0.1 units on a scale
Standard Deviation 0.7
|
1.6 units on a scale
Standard Deviation 0.8
|
1.5 units on a scale
Standard Deviation 1.0
|
1.6 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
2 hour
|
0.0 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 1.0
|
1.7 units on a scale
Standard Deviation 0.9
|
1.5 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
3 hour
|
0.1 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 1.0
|
1.7 units on a scale
Standard Deviation 1.0
|
1.6 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
4 hour
|
0.1 units on a scale
Standard Deviation 0.9
|
1.7 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 1.1
|
1.7 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
5 hour
|
0.1 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 0.9
|
1.5 units on a scale
Standard Deviation 1.1
|
1.6 units on a scale
Standard Deviation 1.0
|
1.5 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
6 hour
|
0.2 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 1.1
|
1.6 units on a scale
Standard Deviation 1.1
|
1.3 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
7 hour
|
0.2 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 1.1
|
1.3 units on a scale
Standard Deviation 1.1
|
1.2 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
8 hour
|
0.2 units on a scale
Standard Deviation 0.9
|
0.9 units on a scale
Standard Deviation 1.0
|
1.0 units on a scale
Standard Deviation 1.0
|
1.0 units on a scale
Standard Deviation 1.0
|
1.0 units on a scale
Standard Deviation 1.1
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
9 hour
|
0.2 units on a scale
Standard Deviation 0.9
|
0.8 units on a scale
Standard Deviation 1.0
|
0.7 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 0.9
|
0.8 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
10 hour
|
0.2 units on a scale
Standard Deviation 1.0
|
0.6 units on a scale
Standard Deviation 0.9
|
0.6 units on a scale
Standard Deviation 0.9
|
0.7 units on a scale
Standard Deviation 0.9
|
0.7 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
11 hour
|
0.2 units on a scale
Standard Deviation 1.0
|
0.5 units on a scale
Standard Deviation 1.0
|
0.5 units on a scale
Standard Deviation 0.9
|
0.6 units on a scale
Standard Deviation 0.9
|
0.6 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
12 hour
|
0.3 units on a scale
Standard Deviation 1.1
|
0.3 units on a scale
Standard Deviation 0.8
|
0.4 units on a scale
Standard Deviation 0.8
|
0.4 units on a scale
Standard Deviation 0.8
|
0.5 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
11 hour
|
0.6 units on a scale
Standard Deviation 2.9
|
1.6 units on a scale
Standard Deviation 2.8
|
1.7 units on a scale
Standard Deviation 2.9
|
2.0 units on a scale
Standard Deviation 2.6
|
2.2 units on a scale
Standard Deviation 2.9
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
7 hour
|
0.3 units on a scale
Standard Deviation 2.5
|
3.9 units on a scale
Standard Deviation 2.9
|
4.2 units on a scale
Standard Deviation 3.2
|
4.2 units on a scale
Standard Deviation 3.1
|
3.9 units on a scale
Standard Deviation 3.2
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
8 hour
|
0.3 units on a scale
Standard Deviation 2.6
|
3.1 units on a scale
Standard Deviation 3.0
|
3.5 units on a scale
Standard Deviation 3.2
|
3.2 units on a scale
Standard Deviation 3.0
|
3.5 units on a scale
Standard Deviation 3.2
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
9 hour
|
0.5 units on a scale
Standard Deviation 2.8
|
2.5 units on a scale
Standard Deviation 3.0
|
2.7 units on a scale
Standard Deviation 3.1
|
2.8 units on a scale
Standard Deviation 3.0
|
2.9 units on a scale
Standard Deviation 3.0
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
10 hour
|
0.6 units on a scale
Standard Deviation 3.0
|
1.9 units on a scale
Standard Deviation 2.8
|
2.1 units on a scale
Standard Deviation 3.0
|
2.5 units on a scale
Standard Deviation 2.9
|
2.5 units on a scale
Standard Deviation 3.0
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
12 hour
|
0.7 units on a scale
Standard Deviation 3.2
|
1.1 units on a scale
Standard Deviation 2.4
|
1.5 units on a scale
Standard Deviation 2.6
|
1.7 units on a scale
Standard Deviation 2.5
|
1.9 units on a scale
Standard Deviation 2.6
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
0.25 hour
|
0.1 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 1.6
|
0.8 units on a scale
Standard Deviation 1.3
|
0.9 units on a scale
Standard Deviation 1.6
|
0.4 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
0.5 hour
|
0.2 units on a scale
Standard Deviation 1.1
|
3.0 units on a scale
Standard Deviation 2.3
|
2.5 units on a scale
Standard Deviation 2.3
|
2.6 units on a scale
Standard Deviation 2.3
|
1.7 units on a scale
Standard Deviation 1.8
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
1 hour
|
0.1 units on a scale
Standard Deviation 1.4
|
4.7 units on a scale
Standard Deviation 2.5
|
4.2 units on a scale
Standard Deviation 2.6
|
4.5 units on a scale
Standard Deviation 2.4
|
3.8 units on a scale
Standard Deviation 2.6
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
1.5 hour
|
0.0 units on a scale
Standard Deviation 1.7
|
5.3 units on a scale
Standard Deviation 2.4
|
5.0 units on a scale
Standard Deviation 2.8
|
5.3 units on a scale
Standard Deviation 2.4
|
4.6 units on a scale
Standard Deviation 2.7
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
2 hour
|
-0.1 units on a scale
Standard Deviation 1.8
|
5.5 units on a scale
Standard Deviation 2.5
|
5.3 units on a scale
Standard Deviation 3.0
|
5.6 units on a scale
Standard Deviation 2.5
|
5.0 units on a scale
Standard Deviation 2.8
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
3 hour
|
0.1 units on a scale
Standard Deviation 2.2
|
5.7 units on a scale
Standard Deviation 2.5
|
5.5 units on a scale
Standard Deviation 3.0
|
5.7 units on a scale
Standard Deviation 2.7
|
5.2 units on a scale
Standard Deviation 2.9
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
4 hour
|
0.3 units on a scale
Standard Deviation 2.5
|
5.5 units on a scale
Standard Deviation 2.5
|
5.4 units on a scale
Standard Deviation 3.1
|
5.6 units on a scale
Standard Deviation 2.7
|
5.1 units on a scale
Standard Deviation 3.0
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
5 hour
|
0.2 units on a scale
Standard Deviation 2.4
|
5.3 units on a scale
Standard Deviation 2.6
|
5.1 units on a scale
Standard Deviation 3.2
|
5.3 units on a scale
Standard Deviation 3.0
|
4.9 units on a scale
Standard Deviation 3.0
|
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
6 hour
|
0.4 units on a scale
Standard Deviation 2.6
|
4.6 units on a scale
Standard Deviation 2.9
|
4.8 units on a scale
Standard Deviation 3.3
|
5.0 units on a scale
Standard Deviation 3.1
|
4.4 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[no pain\] to 3 \[worst possible pain\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
0.25 hour
|
0.3 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 1.3
|
0.7 units on a scale
Standard Deviation 1.1
|
1.0 units on a scale
Standard Deviation 1.4
|
0.6 units on a scale
Standard Deviation 1.0
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
0.5 hour
|
0.3 units on a scale
Standard Deviation 0.9
|
2.6 units on a scale
Standard Deviation 1.8
|
2.2 units on a scale
Standard Deviation 1.9
|
2.4 units on a scale
Standard Deviation 1.8
|
1.6 units on a scale
Standard Deviation 1.4
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
1 hour
|
0.5 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.8
|
3.6 units on a scale
Standard Deviation 1.8
|
3.9 units on a scale
Standard Deviation 1.9
|
3.2 units on a scale
Standard Deviation 1.9
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
1.5 hour
|
0.5 units on a scale
Standard Deviation 1.4
|
4.5 units on a scale
Standard Deviation 1.7
|
4.1 units on a scale
Standard Deviation 2.0
|
4.5 units on a scale
Standard Deviation 1.8
|
3.9 units on a scale
Standard Deviation 1.9
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
2 hour
|
0.4 units on a scale
Standard Deviation 1.4
|
4.6 units on a scale
Standard Deviation 1.8
|
4.3 units on a scale
Standard Deviation 2.1
|
4.7 units on a scale
Standard Deviation 1.9
|
4.2 units on a scale
Standard Deviation 2.1
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
3 hour
|
0.6 units on a scale
Standard Deviation 1.8
|
4.6 units on a scale
Standard Deviation 1.8
|
4.4 units on a scale
Standard Deviation 2.2
|
4.7 units on a scale
Standard Deviation 2.0
|
4.3 units on a scale
Standard Deviation 2.2
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
4 hour
|
0.7 units on a scale
Standard Deviation 1.9
|
4.5 units on a scale
Standard Deviation 1.8
|
4.3 units on a scale
Standard Deviation 2.3
|
4.6 units on a scale
Standard Deviation 2.0
|
4.2 units on a scale
Standard Deviation 2.3
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
5 hour
|
0.6 units on a scale
Standard Deviation 1.9
|
4.3 units on a scale
Standard Deviation 1.9
|
4.1 units on a scale
Standard Deviation 2.4
|
4.4 units on a scale
Standard Deviation 2.3
|
4.1 units on a scale
Standard Deviation 2.3
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
6 hour
|
0.8 units on a scale
Standard Deviation 2.0
|
3.8 units on a scale
Standard Deviation 2.2
|
3.9 units on a scale
Standard Deviation 2.4
|
4.2 units on a scale
Standard Deviation 2.4
|
3.7 units on a scale
Standard Deviation 2.5
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
7 hour
|
0.7 units on a scale
Standard Deviation 2.0
|
3.3 units on a scale
Standard Deviation 2.3
|
3.4 units on a scale
Standard Deviation 2.4
|
3.6 units on a scale
Standard Deviation 2.4
|
3.3 units on a scale
Standard Deviation 2.5
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
8 hour
|
0.7 units on a scale
Standard Deviation 2.0
|
2.7 units on a scale
Standard Deviation 2.4
|
2.9 units on a scale
Standard Deviation 2.3
|
2.8 units on a scale
Standard Deviation 2.4
|
3.0 units on a scale
Standard Deviation 2.5
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
9 hour
|
0.8 units on a scale
Standard Deviation 2.0
|
2.2 units on a scale
Standard Deviation 2.4
|
2.2 units on a scale
Standard Deviation 2.3
|
2.5 units on a scale
Standard Deviation 2.3
|
2.5 units on a scale
Standard Deviation 2.4
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
10 hour
|
0.8 units on a scale
Standard Deviation 2.2
|
1.7 units on a scale
Standard Deviation 2.3
|
1.7 units on a scale
Standard Deviation 2.2
|
2.2 units on a scale
Standard Deviation 2.3
|
2.1 units on a scale
Standard Deviation 2.4
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
11 hour
|
0.9 units on a scale
Standard Deviation 2.3
|
1.4 units on a scale
Standard Deviation 2.3
|
1.5 units on a scale
Standard Deviation 2.2
|
1.9 units on a scale
Standard Deviation 2.2
|
1.9 units on a scale
Standard Deviation 2.4
|
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
12 hour
|
0.9 units on a scale
Standard Deviation 2.4
|
1.1 units on a scale
Standard Deviation 2.0
|
1.2 units on a scale
Standard Deviation 2.0
|
1.6 units on a scale
Standard Deviation 2.1
|
1.7 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose
0 to 8 hours
|
1.0 units on a scale
Standard Deviation 6.1
|
11.2 units on a scale
Standard Deviation 6.1
|
10.7 units on a scale
Standard Deviation 7.2
|
11.6 units on a scale
Standard Deviation 6.6
|
10.4 units on a scale
Standard Deviation 6.7
|
|
Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose
0 to 2 hours
|
0.1 units on a scale
Standard Deviation 1.0
|
2.7 units on a scale
Standard Deviation 1.5
|
2.4 units on a scale
Standard Deviation 1.5
|
2.7 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 1.4
|
|
Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose
0 to 6 hours
|
0.7 units on a scale
Standard Deviation 4.4
|
9.1 units on a scale
Standard Deviation 4.5
|
8.5 units on a scale
Standard Deviation 5.4
|
9.3 units on a scale
Standard Deviation 5.0
|
8.2 units on a scale
Standard Deviation 4.9
|
|
Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose
0 to 12 hours
|
2.0 units on a scale
Standard Deviation 10.0
|
13.3 units on a scale
Standard Deviation 8.8
|
12.9 units on a scale
Standard Deviation 9.9
|
14.1 units on a scale
Standard Deviation 9.1
|
13.0 units on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -40 (worst score) to 80 (best score) for SPID 0-8, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose
0 to 2 hours
|
0.1 units on a scale
Standard Deviation 2.4
|
8.8 units on a scale
Standard Deviation 4.3
|
8.0 units on a scale
Standard Deviation 4.5
|
8.6 units on a scale
Standard Deviation 4.0
|
7.2 units on a scale
Standard Deviation 4.3
|
|
Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose
0 to 6 hours
|
1.1 units on a scale
Standard Deviation 11.8
|
29.9 units on a scale
Standard Deviation 13.0
|
28.8 units on a scale
Standard Deviation 16.1
|
30.1 units on a scale
Standard Deviation 14.4
|
26.8 units on a scale
Standard Deviation 15.0
|
|
Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose
0 to 8 hours
|
1.8 units on a scale
Standard Deviation 16.8
|
36.9 units on a scale
Standard Deviation 17.3
|
36.5 units on a scale
Standard Deviation 21.5
|
37.6 units on a scale
Standard Deviation 19.3
|
34.2 units on a scale
Standard Deviation 20.3
|
|
Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose
0 to12 hours
|
4.1 units on a scale
Standard Deviation 28.7
|
44.0 units on a scale
Standard Deviation 25.0
|
44.5 units on a scale
Standard Deviation 29.7
|
46.5 units on a scale
Standard Deviation 27.3
|
43.7 units on a scale
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
TOTPAR: time-weighted sum of PRR scores over 2, 6, 8 and 12 hours. TOTPAR score range was 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale where 0= No relief to 4= Complete relief.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose
0 to 2 hours
|
0.7 units on a scale
Standard Deviation 1.1
|
4.7 units on a scale
Standard Deviation 1.7
|
4.3 units on a scale
Standard Deviation 1.9
|
4.7 units on a scale
Standard Deviation 1.8
|
4.0 units on a scale
Standard Deviation 1.8
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose
0 to 6 hours
|
2.8 units on a scale
Standard Deviation 5.4
|
15.7 units on a scale
Standard Deviation 5.2
|
14.8 units on a scale
Standard Deviation 6.5
|
16.0 units on a scale
Standard Deviation 6.3
|
14.3 units on a scale
Standard Deviation 6.7
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose
0 to 8 hours
|
4.0 units on a scale
Standard Deviation 7.6
|
19.6 units on a scale
Standard Deviation 7.2
|
18.9 units on a scale
Standard Deviation 8.8
|
20.2 units on a scale
Standard Deviation 8.6
|
18.4 units on a scale
Standard Deviation 9.2
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose
0 to 12 hours
|
6.4 units on a scale
Standard Deviation 12.6
|
23.9 units on a scale
Standard Deviation 11.2
|
23.4 units on a scale
Standard Deviation 12.6
|
25.8 units on a scale
Standard Deviation 12.9
|
23.9 units on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6 and -12 (worst score) to 84 (best score) for SPRID 0-12. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 \[none\] to 3 \[severe\]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose
0 to 6 hours
|
3.5 units on a scale
Standard Deviation 9.4
|
24.8 units on a scale
Standard Deviation 9.2
|
23.3 units on a scale
Standard Deviation 11.6
|
25.3 units on a scale
Standard Deviation 10.9
|
22.5 units on a scale
Standard Deviation 11.2
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose
0 to 2 hours
|
0.9 units on a scale
Standard Deviation 2.0
|
7.4 units on a scale
Standard Deviation 3.0
|
6.7 units on a scale
Standard Deviation 3.2
|
7.4 units on a scale
Standard Deviation 3.1
|
6.2 units on a scale
Standard Deviation 3.1
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose
0 to 12 hours
|
8.4 units on a scale
Standard Deviation 22.0
|
37.2 units on a scale
Standard Deviation 19.2
|
36.3 units on a scale
Standard Deviation 21.9
|
39.9 units on a scale
Standard Deviation 21.1
|
36.9 units on a scale
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Cumulative Percentage of Participants With Meaningful Relief
7 hours
|
16.7 percentage of participants
|
91.1 percentage of participants
|
87.1 percentage of participants
|
89.9 percentage of participants
|
84.8 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
8 hours
|
16.7 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
10 hours
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
11 hours
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
12 hours
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
0.5 hours
|
0.0 percentage of participants
|
33.3 percentage of participants
|
23.7 percentage of participants
|
22.5 percentage of participants
|
13.0 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
1 hour
|
3.3 percentage of participants
|
65.6 percentage of participants
|
54.8 percentage of participants
|
67.4 percentage of participants
|
54.3 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
9 hours
|
16.7 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
0.25 hours
|
0.0 percentage of participants
|
1.1 percentage of participants
|
1.1 percentage of participants
|
3.4 percentage of participants
|
1.1 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
1.5 hours
|
6.7 percentage of participants
|
81.1 percentage of participants
|
69.9 percentage of participants
|
77.5 percentage of participants
|
66.3 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
2 hours
|
10.0 percentage of participants
|
85.6 percentage of participants
|
77.4 percentage of participants
|
84.3 percentage of participants
|
73.9 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
3 hours
|
10.0 percentage of participants
|
90.0 percentage of participants
|
81.7 percentage of participants
|
88.8 percentage of participants
|
80.4 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
4 hours
|
13.3 percentage of participants
|
90.0 percentage of participants
|
83.9 percentage of participants
|
89.9 percentage of participants
|
81.5 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
5 hours
|
13.3 percentage of participants
|
91.1 percentage of participants
|
84.9 percentage of participants
|
89.9 percentage of participants
|
82.6 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
6 hours
|
16.7 percentage of participants
|
91.1 percentage of participants
|
86.0 percentage of participants
|
89.9 percentage of participants
|
83.7 percentage of participants
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
1.5 hour
|
16.7 percentage of participants
|
91.1 percentage of participants
|
86.0 percentage of participants
|
89.9 percentage of participants
|
84.8 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
2 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
5 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
6 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
8 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
0.25 hour
|
3.3 percentage of participants
|
26.7 percentage of participants
|
18.3 percentage of participants
|
28.1 percentage of participants
|
19.6 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
0.5 hour
|
10.0 percentage of participants
|
73.3 percentage of participants
|
66.7 percentage of participants
|
77.5 percentage of participants
|
63.0 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
1 hour
|
16.7 percentage of participants
|
88.9 percentage of participants
|
83.9 percentage of participants
|
88.8 percentage of participants
|
80.4 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
3 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
4 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
7 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
9 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
10 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
11 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
12 hour
|
20.0 percentage of participants
|
91.1 percentage of participants
|
88.2 percentage of participants
|
89.9 percentage of participants
|
85.9 percentage of participants
|
SECONDARY outcome
Timeframe: From 0 hour up to 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Time to Treatment Failure
|
1.6 hours
Interval 1.3 to 1.8
|
9.7 hours
Interval 8.7 to
Upper limit of confidence interval was not estimable as it was \>720 minutes/12 hours) for Ibuprofen 200 mg + Acetaminophen 500 mg group.
|
10.1 hours
Interval 9.2 to 12.0
|
11.1 hours
Interval 9.2 to
Upper limit of confidence interval was not estimable as it was \>720 minutes/12 hours) for Ibuprofen 300 mg + Acetaminophen 500 mg group.
|
10.4 hours
Interval 9.2 to
Upper limit of confidence interval was not estimable as it was \>720 minutes/12 hours) for Ibuprofen 400 mg group.
|
SECONDARY outcome
Timeframe: 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Cumulative Percentage of Participants With Treatment Failure
2 hour
|
73.3 percentage of participants
|
2.2 percentage of participants
|
6.5 percentage of participants
|
5.6 percentage of participants
|
10.9 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
1.5 hour
|
43.3 percentage of participants
|
2.2 percentage of participants
|
2.2 percentage of participants
|
4.5 percentage of participants
|
5.4 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
3 hour
|
80.0 percentage of participants
|
2.2 percentage of participants
|
8.6 percentage of participants
|
6.7 percentage of participants
|
13.0 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
4 hour
|
80.0 percentage of participants
|
3.3 percentage of participants
|
9.7 percentage of participants
|
7.9 percentage of participants
|
15.2 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
5 hour
|
80.0 percentage of participants
|
4.4 percentage of participants
|
14.0 percentage of participants
|
10.1 percentage of participants
|
15.2 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
6 hour
|
80.0 percentage of participants
|
8.9 percentage of participants
|
18.3 percentage of participants
|
14.6 percentage of participants
|
20.7 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
7 hour
|
80.0 percentage of participants
|
17.8 percentage of participants
|
20.4 percentage of participants
|
15.7 percentage of participants
|
27.2 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
8 hour
|
80.0 percentage of participants
|
28.9 percentage of participants
|
23.7 percentage of participants
|
25.8 percentage of participants
|
32.6 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
9 hour
|
80.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
36.0 percentage of participants
|
35.9 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
10 hour
|
80.0 percentage of participants
|
51.1 percentage of participants
|
46.2 percentage of participants
|
42.7 percentage of participants
|
45.7 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
11 hour
|
80.0 percentage of participants
|
57.8 percentage of participants
|
53.8 percentage of participants
|
48.3 percentage of participants
|
53.3 percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
12 hour
|
80.0 percentage of participants
|
64.4 percentage of participants
|
57.0 percentage of participants
|
50.6 percentage of participants
|
55.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 hourPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 Participants
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 Participants
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Participant Global Evaluation of Study Medication
|
1.0 units on a scale
Standard Deviation 1.5
|
3.8 units on a scale
Standard Deviation 1.1
|
3.4 units on a scale
Standard Deviation 1.2
|
3.6 units on a scale
Standard Deviation 1.2
|
3.5 units on a scale
Standard Deviation 1.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Ibuprofen 200 mg + Acetaminophen 500 mg
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Ibuprofen 250 mg + Acetaminophen 500 mg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Ibuprofen 300 mg + Acetaminophen 500 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Ibuprofen 400 mg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=30 participants at risk
Participants received Placebo as single oral dose caplets during the 12 hours study.
|
Ibuprofen 200 mg + Acetaminophen 500 mg
n=90 participants at risk
Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 250 mg + Acetaminophen 500 mg
n=93 participants at risk
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 300 mg + Acetaminophen 500 mg
n=89 participants at risk
Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
|
Ibuprofen 400 mg
n=92 participants at risk
Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Dizziness
|
10.0%
3/30
|
10.0%
9/90
|
6.5%
6/93
|
7.9%
7/89
|
7.6%
7/92
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30
|
0.00%
0/90
|
2.2%
2/93
|
0.00%
0/89
|
0.00%
0/92
|
|
Gastrointestinal disorders
Alveolar osteitis
|
0.00%
0/30
|
4.4%
4/90
|
2.2%
2/93
|
1.1%
1/89
|
2.2%
2/92
|
|
Gastrointestinal disorders
Nausea
|
46.7%
14/30
|
24.4%
22/90
|
19.4%
18/93
|
18.0%
16/89
|
23.9%
22/92
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
7/30
|
8.9%
8/90
|
11.8%
11/93
|
5.6%
5/89
|
15.2%
14/92
|
|
General disorders
Feeling hot
|
6.7%
2/30
|
4.4%
4/90
|
1.1%
1/93
|
4.5%
4/89
|
4.3%
4/92
|
|
General disorders
Hyperhidrosis
|
0.00%
0/30
|
2.2%
2/90
|
0.00%
0/93
|
2.2%
2/89
|
0.00%
0/92
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.3%
1/30
|
0.00%
0/90
|
0.00%
0/93
|
0.00%
0/89
|
0.00%
0/92
|
|
Nervous system disorders
Tension headache
|
0.00%
0/30
|
4.4%
4/90
|
1.1%
1/93
|
1.1%
1/89
|
4.3%
4/92
|
|
Nervous system disorders
Paraesthesia
|
3.3%
1/30
|
0.00%
0/90
|
0.00%
0/93
|
0.00%
0/89
|
0.00%
0/92
|
|
Nervous system disorders
Somnolence
|
0.00%
0/30
|
0.00%
0/90
|
1.1%
1/93
|
0.00%
0/89
|
2.2%
2/92
|
|
Nervous system disorders
Tremor
|
3.3%
1/30
|
1.1%
1/90
|
2.2%
2/93
|
3.4%
3/89
|
2.2%
2/92
|
|
Vascular disorders
Post procedural haemorrhage
|
0.00%
0/30
|
0.00%
0/90
|
2.2%
2/93
|
3.4%
3/89
|
0.00%
0/92
|
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