Trial Outcomes & Findings for Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain (NCT NCT01098747)
NCT ID: NCT01098747
Last Updated: 2012-08-17
Results Overview
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
COMPLETED
PHASE3
335 participants
0 to 8 hours
2012-08-17
Participant Flow
Participant milestones
| Measure |
Placebo
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil)
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
|
Ibuprofen (Motrin IB)
Single oral dose of 2 ibuprofen \[Motrin ibuprofen (IB)\] 200 mg tablets (total dose of 400 mg ibuprofen).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
95
|
86
|
87
|
|
Overall Study
COMPLETED
|
48
|
95
|
86
|
87
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil)
n=86 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
|
Ibuprofen (Motrin IB)
n=87 Participants
Single oral dose of 2 ibuprofen \[Motrin ibuprofen (IB)\] 200 mg tablets (total dose of 400 mg ibuprofen).
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
18.1 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
18.6 Years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
18.6 Years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
18.4 Years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
18.5 Years
STANDARD_DEVIATION 2.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Number of Participants with Pain Severity Score
Moderate
|
27 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
Number of Participants with Pain Severity Score
Severe
|
21 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0 to 8 hoursPopulation: Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
|
5.4 Units on a scale
Standard Deviation 14.1
|
29.8 Units on a scale
Standard Deviation 14.2
|
—
|
PRIMARY outcome
Timeframe: 0 to 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participants evaluated the 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 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Time to Onset of Meaningful Relief
|
NA Minutes
Data was not summarized as median time to meaningful relief was greater than (\>) 480 minutes (\>8 hours) for placebo group and therefore 95% CI was not estimable.
|
42.4 Minutes
Interval 38.5 to 46.6
|
55.3 Minutes
Interval 49.6 to 64.3
|
SECONDARY outcome
Timeframe: 0 to 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Time to Confirmed First Perceptible Relief
|
NA Minutes
Data was not summarized as median time to confirmed first perceptible relief was \>480 minutes (\>8 hours) for placebo group and therefore 95% CI was not estimable.
|
16.4 Minutes
Interval 15.6 to 19.3
|
25.7 Minutes
Interval 22.2 to 29.1
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). 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=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Pain Relief Rating (PRR)
0.25 hours
|
0.4 Units on a scale
Standard Deviation 0.6
|
0.7 Units on a scale
Standard Deviation 0.8
|
0.5 Units on a scale
Standard Deviation 0.7
|
|
Pain Relief Rating (PRR)
0.5 hours
|
0.5 Units on a scale
Standard Deviation 0.7
|
2.0 Units on a scale
Standard Deviation 1.1
|
1.5 Units on a scale
Standard Deviation 1.1
|
|
Pain Relief Rating (PRR)
1 hour
|
0.6 Units on a scale
Standard Deviation 1.0
|
2.9 Units on a scale
Standard Deviation 1.0
|
2.5 Units on a scale
Standard Deviation 1.1
|
|
Pain Relief Rating (PRR)
1.5 hours
|
0.7 Units on a scale
Standard Deviation 1.1
|
3.1 Units on a scale
Standard Deviation 1.0
|
2.8 Units on a scale
Standard Deviation 1.2
|
|
Pain Relief Rating (PRR)
2 hours
|
0.7 Units on a scale
Standard Deviation 1.2
|
3.1 Units on a scale
Standard Deviation 1.1
|
3.0 Units on a scale
Standard Deviation 1.2
|
|
Pain Relief Rating (PRR)
3 hours
|
0.7 Units on a scale
Standard Deviation 1.2
|
2.9 Units on a scale
Standard Deviation 1.2
|
3.0 Units on a scale
Standard Deviation 1.2
|
|
Pain Relief Rating (PRR)
4 hours
|
0.8 Units on a scale
Standard Deviation 1.3
|
2.8 Units on a scale
Standard Deviation 1.2
|
3.0 Units on a scale
Standard Deviation 1.2
|
|
Pain Relief Rating (PRR)
5 hours
|
0.7 Units on a scale
Standard Deviation 1.3
|
2.6 Units on a scale
Standard Deviation 1.3
|
2.8 Units on a scale
Standard Deviation 1.3
|
|
Pain Relief Rating (PRR)
6 hours
|
0.7 Units on a scale
Standard Deviation 1.2
|
2.3 Units on a scale
Standard Deviation 1.4
|
2.6 Units on a scale
Standard Deviation 1.4
|
|
Pain Relief Rating (PRR)
7 hours
|
0.5 Units on a scale
Standard Deviation 1.1
|
1.9 Units on a scale
Standard Deviation 1.4
|
2.3 Units on a scale
Standard Deviation 1.5
|
|
Pain Relief Rating (PRR)
8 hours
|
0.5 Units on a scale
Standard Deviation 1.1
|
1.7 Units on a scale
Standard Deviation 1.4
|
2.2 Units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best).
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Pain Intensity Difference (PID)
7 hours
|
-0.0 Units on a scale
Standard Deviation 0.9
|
0.9 Units on a scale
Standard Deviation 1.0
|
1.2 Units on a scale
Standard Deviation 1.1
|
|
Pain Intensity Difference (PID)
0.25 hours
|
0.0 Units on a scale
Standard Deviation 0.4
|
0.3 Units on a scale
Standard Deviation 0.5
|
0.1 Units on a scale
Standard Deviation 0.5
|
|
Pain Intensity Difference (PID)
0.5 hours
|
0.0 Units on a scale
Standard Deviation 0.5
|
1.0 Units on a scale
Standard Deviation 0.7
|
0.6 Units on a scale
Standard Deviation 0.8
|
|
Pain Intensity Difference (PID)
1 hour
|
0.0 Units on a scale
Standard Deviation 0.7
|
1.5 Units on a scale
Standard Deviation 0.9
|
1.3 Units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID)
1.5 hour
|
0.0 Units on a scale
Standard Deviation 0.8
|
1.7 Units on a scale
Standard Deviation 0.9
|
1.5 Units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID)
2 hours
|
0.0 Units on a scale
Standard Deviation 0.9
|
1.8 Units on a scale
Standard Deviation 0.9
|
1.7 Units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID)
3 hours
|
0.0 Units on a scale
Standard Deviation 0.9
|
1.6 Units on a scale
Standard Deviation 0.9
|
1.7 Units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID)
4 hours
|
0.1 Units on a scale
Standard Deviation 1.0
|
1.5 Units on a scale
Standard Deviation 0.9
|
1.7 Units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID)
5 hours
|
0.0 Units on a scale
Standard Deviation 1.0
|
1.4 Units on a scale
Standard Deviation 1.0
|
1.6 Units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID)
6 hours
|
-0.0 Units on a scale
Standard Deviation 0.9
|
1.2 Units on a scale
Standard Deviation 1.0
|
1.5 Units on a scale
Standard Deviation 1.1
|
|
Pain Intensity Difference (PID)
8 hours
|
-0.0 Units on a scale
Standard Deviation 0.8
|
0.8 Units on a scale
Standard Deviation 1.0
|
1.1 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
0.25 hours
|
0.4 Units on a scale
Standard Deviation 0.9
|
1.1 Units on a scale
Standard Deviation 1.2
|
0.6 Units on a scale
Standard Deviation 1.1
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
0.5 hours
|
0.6 Units on a scale
Standard Deviation 1.2
|
3.0 Units on a scale
Standard Deviation 1.7
|
2.1 Units on a scale
Standard Deviation 1.8
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
1 hour
|
0.7 Units on a scale
Standard Deviation 1.6
|
4.4 Units on a scale
Standard Deviation 1.8
|
3.8 Units on a scale
Standard Deviation 2.0
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
1.5 hours
|
0.7 Units on a scale
Standard Deviation 1.8
|
4.8 Units on a scale
Standard Deviation 1.8
|
4.3 Units on a scale
Standard Deviation 2.0
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
2 hours
|
0.8 Units on a scale
Standard Deviation 2.0
|
4.9 Units on a scale
Standard Deviation 1.8
|
4.7 Units on a scale
Standard Deviation 2.0
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
3 hours
|
0.7 Units on a scale
Standard Deviation 2.0
|
4.5 Units on a scale
Standard Deviation 2.0
|
4.7 Units on a scale
Standard Deviation 2.1
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
4 hours
|
0.9 Units on a scale
Standard Deviation 2.3
|
4.3 Units on a scale
Standard Deviation 2.1
|
4.8 Units on a scale
Standard Deviation 2.2
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
5 hours
|
0.8 Units on a scale
Standard Deviation 2.1
|
4.0 Units on a scale
Standard Deviation 2.2
|
4.4 Units on a scale
Standard Deviation 2.2
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
6 hours
|
0.6 Units on a scale
Standard Deviation 2.0
|
3.5 Units on a scale
Standard Deviation 2.2
|
4.1 Units on a scale
Standard Deviation 2.4
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
7 hours
|
0.5 Units on a scale
Standard Deviation 1.9
|
2.9 Units on a scale
Standard Deviation 2.3
|
3.5 Units on a scale
Standard Deviation 2.5
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
8 hours
|
0.5 Units on a scale
Standard Deviation 1.8
|
2.6 Units on a scale
Standard Deviation 2.3
|
3.2 Units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 0-2, 0-3, 0-6, 0-8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best).
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-2
|
0.1 Units on a scale
Standard Deviation 1.3
|
2.8 Units on a scale
Standard Deviation 1.4
|
2.4 Units on a scale
Standard Deviation 1.5
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-3
|
0.1 Units on a scale
Standard Deviation 2.1
|
4.4 Units on a scale
Standard Deviation 2.2
|
4.1 Units on a scale
Standard Deviation 2.3
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-6
|
0.2 Units on a scale
Standard Deviation 4.8
|
8.5 Units on a scale
Standard Deviation 4.7
|
8.9 Units on a scale
Standard Deviation 5.0
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-8
|
0.1 Units on a scale
Standard Deviation 6.4
|
10.2 Units on a scale
Standard Deviation 6.3
|
11.1 Units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 0-2, 0-3, 0-6, 0-8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-2
|
1.3 Units on a scale
Standard Deviation 1.8
|
5.2 Units on a scale
Standard Deviation 1.7
|
4.6 Units on a scale
Standard Deviation 1.9
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-3
|
2.0 Units on a scale
Standard Deviation 2.9
|
8.1 Units on a scale
Standard Deviation 2.7
|
7.6 Units on a scale
Standard Deviation 2.8
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-6
|
4.2 Units on a scale
Standard Deviation 6.5
|
15.9 Units on a scale
Standard Deviation 6.1
|
16.1 Units on a scale
Standard Deviation 6.1
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-8
|
5.2 Units on a scale
Standard Deviation 8.4
|
19.5 Units on a scale
Standard Deviation 8.5
|
20.6 Units on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 0-2, 0-3, 0-6, 0-8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-2
|
1.3 Units on a scale
Standard Deviation 2.9
|
8.0 Units on a scale
Standard Deviation 3.0
|
7.0 Units on a scale
Standard Deviation 3.3
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-3
|
2.1 Units on a scale
Standard Deviation 4.8
|
12.6 Units on a scale
Standard Deviation 4.7
|
11.8 Units on a scale
Standard Deviation 4.9
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-6
|
4.4 Units on a scale
Standard Deviation 10.8
|
24.3 Units on a scale
Standard Deviation 10.4
|
25.0 Units on a scale
Standard Deviation 10.6
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-8
|
5.4 Units on a scale
Standard Deviation 14.1
|
29.8 Units on a scale
Standard Deviation 14.2
|
31.7 Units on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Meaningful Relief
0.25 hours
|
0.0 Percentage of participants
|
1.1 Percentage of participants
|
0.6 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
0.5 hours
|
4.2 Percentage of participants
|
28.4 Percentage of participants
|
16.8 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
1 hour
|
12.5 Percentage of participants
|
73.7 Percentage of participants
|
52.6 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
1.5 hours
|
14.6 Percentage of participants
|
87.4 Percentage of participants
|
69.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
2 hours
|
18.8 Percentage of participants
|
91.6 Percentage of participants
|
79.8 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
3 hours
|
20.8 Percentage of participants
|
94.7 Percentage of participants
|
86.7 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
4 hours
|
20.8 Percentage of participants
|
94.7 Percentage of participants
|
87.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
5 hours
|
20.8 Percentage of participants
|
94.7 Percentage of participants
|
87.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
6 hours
|
20.8 Percentage of participants
|
94.7 Percentage of participants
|
87.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
7 hours
|
20.8 Percentage of participants
|
95.8 Percentage of participants
|
87.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
8 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
88.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
0.25 hours
|
6.3 Percentage of participants
|
26.3 Percentage of participants
|
12.1 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
0.5 hours
|
14.6 Percentage of participants
|
84.2 Percentage of participants
|
60.7 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
1 hour
|
20.8 Percentage of participants
|
94.7 Percentage of participants
|
84.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
1.5 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
87.3 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
2 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
87.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
3 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
88.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
4 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
88.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
5 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
88.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
6 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
88.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
7 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
88.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
8 hours
|
22.9 Percentage of participants
|
95.8 Percentage of participants
|
88.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Time to Treatment Failure
|
1.7 Hours
Interval 1.6 to 2.1
|
NA Hours
Data was not summarized as median time to treatment failure was \>8 hours for ibuprofen sodium group and therefore 95% CI was not estimable.
|
NA Hours
Data was not summarized as median time to treatment failure was \>8 hours for ibuprofen (Advil + Motrin IB) group and therefore 95% CI was not estimable.
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Outcome measures
| Measure |
Placebo
n=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Treatment Failure
0.25 hours
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
0.5 hours
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
1 hour
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
1.5 hours
|
25.0 Percentage of participants
|
1.1 Percentage of participants
|
2.3 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
2 hours
|
54.2 Percentage of participants
|
2.1 Percentage of participants
|
5.8 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
3 hours
|
70.8 Percentage of participants
|
4.2 Percentage of participants
|
8.1 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
4 hours
|
70.8 Percentage of participants
|
9.5 Percentage of participants
|
8.1 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
5 hours
|
70.8 Percentage of participants
|
10.5 Percentage of participants
|
10.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
6 hours
|
72.9 Percentage of participants
|
13.7 Percentage of participants
|
12.1 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
7 hours
|
77.1 Percentage of participants
|
20.0 Percentage of participants
|
16.2 Percentage of participants
|
|
Cumulative Percentage of Participants With Treatment Failure
8 hours
|
79.2 Percentage of participants
|
26.3 Percentage of participants
|
20.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Complete relief was defined as a PRR of 4. 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=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Complete Relief
0.25 hours
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
0.5 hours
|
0.0 Percentage of participants
|
6.3 Percentage of participants
|
3.5 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
1 hour
|
0.0 Percentage of participants
|
27.4 Percentage of participants
|
20.8 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
1.5 hours
|
0.0 Percentage of participants
|
41.1 Percentage of participants
|
32.4 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
2 hours
|
0.0 Percentage of participants
|
48.4 Percentage of participants
|
43.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
3 hours
|
0.0 Percentage of participants
|
52.6 Percentage of participants
|
54.9 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
4 hours
|
6.3 Percentage of participants
|
54.7 Percentage of participants
|
61.8 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
5 hours
|
6.3 Percentage of participants
|
54.7 Percentage of participants
|
63.0 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
6 hours
|
6.3 Percentage of participants
|
54.7 Percentage of participants
|
63.6 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
7 hours
|
6.3 Percentage of participants
|
54.7 Percentage of participants
|
64.2 Percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
8 hours
|
6.3 Percentage of participants
|
54.7 Percentage of participants
|
64.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: 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 8-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=48 Participants
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 Participants
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil + Motrin IB)
n=173 Participants
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
|
|---|---|---|---|
|
Participant Global Evaluation of Study Medication
|
1.1 Units on a scale
Standard Deviation 1.3
|
3.8 Units on a scale
Standard Deviation 1.0
|
3.7 Units on a scale
Standard Deviation 1.2
|
Adverse Events
Placebo
Ibuprofen Sodium
Ibuprofen (Advil)
Ibuprofen (Motrin IB)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=48 participants at risk
Single oral dose of 2 placebo tablets.
|
Ibuprofen Sodium
n=95 participants at risk
Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
|
Ibuprofen (Advil)
n=86 participants at risk
Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
|
Ibuprofen (Motrin IB)
n=87 participants at risk
Single oral dose of 2 ibuprofen \[Motrin ibuprofen (IB)\] 200 mg tablets (total dose of 400 mg ibuprofen).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.1%
1/48
|
0.00%
0/95
|
0.00%
0/86
|
0.00%
0/87
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/48
|
0.00%
0/95
|
1.2%
1/86
|
0.00%
0/87
|
|
Ear and labyrinth disorders
Ear pain
|
2.1%
1/48
|
0.00%
0/95
|
0.00%
0/86
|
0.00%
0/87
|
|
Cardiac disorders
Dyspnoea
|
0.00%
0/48
|
0.00%
0/95
|
1.2%
1/86
|
0.00%
0/87
|
|
Gastrointestinal disorders
Nausea
|
10.4%
5/48
|
7.4%
7/95
|
7.0%
6/86
|
3.4%
3/87
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
2/48
|
2.1%
2/95
|
3.5%
3/86
|
2.3%
2/87
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/48
|
0.00%
0/95
|
0.00%
0/86
|
1.1%
1/87
|
|
Gastrointestinal disorders
Diarrhoea not otherwise specified
|
0.00%
0/48
|
0.00%
0/95
|
0.00%
0/86
|
1.1%
1/87
|
|
General disorders
Feeling hot
|
4.2%
2/48
|
1.1%
1/95
|
0.00%
0/86
|
2.3%
2/87
|
|
General disorders
Asthenia
|
0.00%
0/48
|
0.00%
0/95
|
0.00%
0/86
|
1.1%
1/87
|
|
General disorders
Feeling cold
|
0.00%
0/48
|
0.00%
0/95
|
1.2%
1/86
|
0.00%
0/87
|
|
General disorders
Hot flush
|
0.00%
0/48
|
0.00%
0/95
|
1.2%
1/86
|
0.00%
0/87
|
|
General disorders
Hyperhidrosis
|
0.00%
0/48
|
0.00%
0/95
|
0.00%
0/86
|
1.1%
1/87
|
|
General disorders
Lethargy
|
0.00%
0/48
|
0.00%
0/95
|
1.2%
1/86
|
0.00%
0/87
|
|
General disorders
Pyrexia
|
0.00%
0/48
|
1.1%
1/95
|
0.00%
0/86
|
0.00%
0/87
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/48
|
0.00%
0/95
|
0.00%
0/86
|
0.00%
0/87
|
|
Nervous system disorders
Headache
|
2.1%
1/48
|
1.1%
1/95
|
4.7%
4/86
|
3.4%
3/87
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48
|
1.1%
1/95
|
3.5%
3/86
|
3.4%
3/87
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/48
|
0.00%
0/95
|
1.2%
1/86
|
0.00%
0/87
|
|
Vascular disorders
Hypotension
|
0.00%
0/48
|
0.00%
0/95
|
0.00%
0/86
|
2.3%
2/87
|
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