Trial Outcomes & Findings for Ibuprofen Sodium Tension Headache Study (NCT NCT01362491)
NCT ID: NCT01362491
Last Updated: 2014-07-30
Results Overview
SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. 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 (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
COMPLETED
PHASE3
226 participants
0-3 Hours
2014-07-30
Participant Flow
Participant milestones
| Measure |
Ibuprofen Sodium
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Ibuprofen (Motrin IB)
Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
89
|
46
|
|
Overall Study
COMPLETED
|
90
|
89
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ibuprofen Sodium
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Ibuprofen (Motrin IB)
Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Overall Study
Ineligible
|
1
|
0
|
0
|
Baseline Characteristics
Ibuprofen Sodium Tension Headache Study
Baseline characteristics by cohort
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Ibuprofen (Motrin IB)
n=89 Participants
Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
39.9 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Pain Severity Score
Moderately Severe
|
73 participants
n=5 Participants
|
70 participants
n=7 Participants
|
36 participants
n=5 Participants
|
179 participants
n=4 Participants
|
|
Pain Severity Score
Severe
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
10 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-3 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 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. 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 (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
|
9.6 units on scale
Standard Deviation 4.8
|
3.5 units on scale
Standard Deviation 4.2
|
—
|
PRIMARY outcome
Timeframe: 0 to 3 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 the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
|
40.6 minutes
Interval 36.7 to 46.8
|
48.5 minutes
Interval 45.5 to 53.5
|
—
|
SECONDARY outcome
Timeframe: 0 to 3 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 the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Time to Onset of Meaningful Relief: Remaining Comparisons
|
40.6 minutes
Interval 36.7 to 46.8
|
48.5 minutes
Interval 45.5 to 53.5
|
NA minutes
Data was not summarized as the median time to onset of meaningful relief was \>180 minutes (\>3 hours) for placebo group and therefore the 95% CI was not estimable.
|
SECONDARY outcome
Timeframe: 0 to 3 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 the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Time to Confirmed First Perceptible Relief
|
36.9 minutes
Interval 34.5 to 40.7
|
43.6 minutes
Interval 40.1 to 48.4
|
NA minutes
Data was not summarized as the median time to first perceptible relief confirmed by meaningful relief was \>180 minutes (\>3 hours) for placebo group and therefore the 95% CI was not estimable.
|
SECONDARY outcome
Timeframe: 1, 2 & 3 hours post-dosePopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Pain Relief Rating (PRR)
3 hours
|
2.8 units on scale
Standard Deviation 1.3
|
2.9 units on scale
Standard Deviation 1.2
|
1.2 units on scale
Standard Deviation 1.2
|
|
Pain Relief Rating (PRR)
1 hour
|
1.5 units on scale
Standard Deviation 1.0
|
1.6 units on scale
Standard Deviation 1.0
|
0.3 units on scale
Standard Deviation 0.7
|
|
Pain Relief Rating (PRR)
2 hours
|
2.3 units on scale
Standard Deviation 1.0
|
2.2 units on scale
Standard Deviation 1.0
|
1.0 units on scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 1, 2 & 3 hours post-dosePopulation: 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 \[Baseline pain severity score range 2 (moderately severe) to 3 (severe)\]. Total possible score range for PID: -1 (worst) to 3 (best).
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Pain Intensity Difference (PID)
2 hours
|
1.0 units on scale
Standard Deviation 0.6
|
1.0 units on scale
Standard Deviation 0.5
|
0.4 units on scale
Standard Deviation 0.6
|
|
Pain Intensity Difference (PID)
3 hours
|
1.3 units on scale
Standard Deviation 0.9
|
1.4 units on scale
Standard Deviation 0.8
|
0.5 units on scale
Standard Deviation 0.8
|
|
Pain Intensity Difference (PID)
1 hour
|
0.7 units on scale
Standard Deviation 0.5
|
0.7 units on scale
Standard Deviation 0.6
|
0.2 units on scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 1, 2 & 3 hours post-dosePopulation: 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 \[Baseline pain severity score range 2 (moderately severe) to 3 (severe)\]. 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 |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
1 hour
|
2.3 units on scale
Standard Deviation 1.4
|
2.2 units on scale
Standard Deviation 1.6
|
0.5 units on scale
Standard Deviation 1.0
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
2 hours
|
3.2 units on scale
Standard Deviation 1.6
|
3.2 units on scale
Standard Deviation 1.5
|
1.4 units on scale
Standard Deviation 1.5
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
3 hours
|
4.1 units on scale
Standard Deviation 2.1
|
4.3 units on scale
Standard Deviation 2.0
|
1.7 units on scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 0 to 2, 0 to 3 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-2
|
1.7 units on scale
Standard Deviation 1.0
|
1.7 units on scale
Standard Deviation 1.0
|
0.5 units on scale
Standard Deviation 0.9
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID 0-3
|
3.0 units on scale
Standard Deviation 1.8
|
3.1 units on scale
Standard Deviation 1.6
|
1.0 units on scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 0 to 2, 0 to 3 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-3
|
6.6 units on scale
Standard Deviation 3.1
|
6.6 units on scale
Standard Deviation 3.0
|
2.5 units on scale
Standard Deviation 2.7
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR 0-2
|
3.8 units on scale
Standard Deviation 1.9
|
3.8 units on scale
Standard Deviation 1.9
|
1.3 units on scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 0 to 2, 0 to 3 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. 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 a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-2
|
5.5 units on scale
Standard Deviation 2.8
|
5.5 units on scale
Standard Deviation 2.8
|
1.8 units on scale
Standard Deviation 2.4
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID 0-3
|
9.6 units on scale
Standard Deviation 4.8
|
9.8 units on scale
Standard Deviation 4.6
|
3.5 units on scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3 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 a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Meaningful Relief
2 hours
|
85.7 percentage of participants
|
86.5 percentage of participants
|
39.1 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
3 hours
|
85.7 percentage of participants
|
86.5 percentage of participants
|
45.7 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
0.5 hours
|
12.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Meaningful Relief
1 hour
|
71.4 percentage of participants
|
65.2 percentage of participants
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3 hoursPopulation: ITT population included all randomized participants who received study medication and provided a baseline assessment.
Percentage of participants with first perceptible relief 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 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".
Outcome measures
| Measure |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With First Perceptible Relief
0.5 hours
|
18.7 percentage of participants
|
7.9 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With First Perceptible Relief
1 hour
|
76.9 percentage of participants
|
74.2 percentage of participants
|
15.2 percentage of participants
|
|
Cumulative Percentage of Participants With First Perceptible Relief
2 hours
|
85.7 percentage of participants
|
86.5 percentage of participants
|
45.7 percentage of participants
|
|
Cumulative Percentage of Participants With First Perceptible Relief
3 hours
|
85.7 percentage of participants
|
86.5 percentage of participants
|
45.7 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 3 hoursPopulation: Population included all randomized patients that reported a treatment failure or received rescue medication.
Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 2, 3 hours post-dosePopulation: ITT population included all randomized patients 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 |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Treatment Failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1, 2, & 3 hours post-dosePopulation: 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 |
Ibuprofen Sodium
n=91 Participants
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
|
Placebo
n=89 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
Placebo
n=46 Participants
Single oral dose of 2 placebo tablets matched to ibuprofen \[Motrin ibuprofen (IB)\] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
|
|---|---|---|---|
|
Cumulative Percentage of Participants With Complete Relief
1 hour
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
2 hours
|
5.5 percentage of participants
|
4.5 percentage of participants
|
2.2 percentage of participants
|
|
Cumulative Percentage of Participants With Complete Relief
3 hours
|
37.4 percentage of participants
|
38.2 percentage of participants
|
8.7 percentage of participants
|
Adverse Events
Ibuprofen Sodium
Ibuprofen (Motrin IB)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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