Trial Outcomes & Findings for Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain (NCT NCT00913627)

Results Overview

Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

196 participants

Primary outcome timeframe

Baseline (0 hour) to 12 hours post dose

Results posted on

2018-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Overall Study STARTED	29	53	56	58
Overall Study COMPLETED	29	53	56	58
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery	Total n=196 Participants Total of all reporting groups
Age, Continuous	18.1 years STANDARD_DEVIATION 2.1 • n=5 Participants	18.6 years STANDARD_DEVIATION 2.4 • n=7 Participants	18.7 years STANDARD_DEVIATION 2.7 • n=5 Participants	18.3 years STANDARD_DEVIATION 2.6 • n=4 Participants	18.5 years STANDARD_DEVIATION 2.5 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	24 Participants n=4 Participants	81 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	31 Participants n=7 Participants	33 Participants n=5 Participants	34 Participants n=4 Participants	115 Participants n=21 Participants
Pain severity Moderate	18 participants n=5 Participants	29 participants n=7 Participants	33 participants n=5 Participants	34 participants n=4 Participants	114 participants n=21 Participants
Pain severity Severe	11 participants n=5 Participants	24 participants n=7 Participants	23 participants n=5 Participants	24 participants n=4 Participants	82 participants n=21 Participants
Pain intensity	73.90 mm STANDARD_DEVIATION 11.60 • n=5 Participants	77.06 mm STANDARD_DEVIATION 13.23 • n=7 Participants	74.80 mm STANDARD_DEVIATION 12.40 • n=5 Participants	75.12 mm STANDARD_DEVIATION 12.30 • n=4 Participants	75.37 mm STANDARD_DEVIATION 12.44 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline (0 hour) to 12 hours post dose

Population: Intent-To-Treat (ITT) population: randomized participants who dosed with study product and provided a baseline pain severity assessment.

Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)	0.05 units on a scale Standard Deviation 9.22	16.87 units on a scale Standard Deviation 9.35	17.34 units on a scale Standard Deviation 10.54	12.66 units on a scale Standard Deviation 10.02

PRIMARY outcome

Timeframe: 8 to 12 hours post dose

Population: ITT population

PID score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)	-0.03 units on a scale Standard Deviation 4.05	6.57 units on a scale Standard Deviation 4.44	7.14 units on a scale Standard Deviation 5.24	5.14 units on a scale Standard Deviation 5.02

SECONDARY outcome

Timeframe: Baseline to 6 hours

Population: ITT population

Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled "first perceptible relief", if the participant also depressed the second stopwatch labelled as "meaningful relief" by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she has currently.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time to First Perceptible Pain Relief	NA minutes Data was not available as median time to onset of first perceptible pain relief was greater than (\>) 360 minutes for placebo group.	29.4 minutes Interval 23.3 to 35.3	29.4 minutes Interval 26.1 to 36.2	32.1 minutes Interval 29.5 to 58.0

SECONDARY outcome

Timeframe: Baseline to 24 hours

Population: ITT population

Time to first rescue medication or discontinuation due to lack of efficacy

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time to Treatment Failure	1.7 hours Interval 1.7 to 2.2	NA hours Data was not available as median time to treatment failure was greater than (\>) 24 hours for Ibuprofen IR/ER (roller compaction)group.	NA hours Data was not available as median time to treatment failure was greater than (\>) 24 hours for Ibuprofen IR/ER (wet granulation)group.	NA hours Data was not available as median time to treatment failure was greater than (\>) 24 hours for Naproxen group.

SECONDARY outcome

Timeframe: 8, 9, 10, 11, and 12 hours

Population: ITT population

Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Percentage of Participants With Treatment Failure 8 hours	82.8 percentage of participants	11.3 percentage of participants	12.5 percentage of participants	24.1 percentage of participants
Percentage of Participants With Treatment Failure 9 hours	82.8 percentage of participants	11.3 percentage of participants	12.5 percentage of participants	25.9 percentage of participants
Percentage of Participants With Treatment Failure 10 hours	82.8 percentage of participants	17.0 percentage of participants	12.5 percentage of participants	27.6 percentage of participants
Percentage of Participants With Treatment Failure 11 hours	82.8 percentage of participants	20.8 percentage of participants	14.3 percentage of participants	27.6 percentage of participants
Percentage of Participants With Treatment Failure 12 hours	82.8 percentage of participants	20.8 percentage of participants	17.9 percentage of participants	32.8 percentage of participants

SECONDARY outcome

Timeframe: 0 to 4 hours and 4 to 8 hours

Population: ITT population

Time-weighted sum of PID score. PID based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8) SPID 0-4	-0.12 units on a scale Standard Deviation 2.57	5.44 units on a scale Standard Deviation 3.21	5.22 units on a scale Standard Deviation 2.90	3.96 units on a scale Standard Deviation 2.87
Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8) SPID 4-8	0.31 units on a scale Standard Deviation 4.57	8.15 units on a scale Standard Deviation 4.48	8.13 units on a scale Standard Deviation 4.76	5.95 units on a scale Standard Deviation 4.74

SECONDARY outcome

Timeframe: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours

Population: ITT population

Time-weighted sum of PRID score where PRID=PID+PR. PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline, ranged from -1 to 3. Baseline pain intensity score of at least 2 required for enrollment. Higher positive PID values = improvement. PR: 5-point categorical pain relief scale None (0), A Little (1), Some (2), A Lot (3) or Complete (4). SPRID 0-4, SPRID 4-8, and SRID 8-12 scores ranged from -4 to 28, SPRID 0-12 ranged from -12 to 84, higher scores = greater improvement.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) SPRID 0-4	1.78 units on a scale Standard Deviation 5.45	15.48 units on a scale Standard Deviation 6.60	15.12 units on a scale Standard Deviation 6.10	11.97 units on a scale Standard Deviation 6.51
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) SPRID 4-8	3.69 units on a scale Standard Deviation 10.63	23.21 units on a scale Standard Deviation 8.85	23.14 units on a scale Standard Deviation 10.12	17.71 units on a scale Standard Deviation 10.69
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) SPRID 8-12	3.00 units on a scale Standard Deviation 9.38	19.36 units on a scale Standard Deviation 9.94	20.73 units on a scale Standard Deviation 11.43	15.86 units on a scale Standard Deviation 11.56
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) SPRID 0-12	7.09 units on a scale Standard Deviation 21.00	48.76 units on a scale Standard Deviation 18.99	50.01 units on a scale Standard Deviation 22.32	38.45 units on a scale Standard Deviation 22.61

SECONDARY outcome

Timeframe: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours

Population: ITT population

TOTPAR based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief). For time-weighted sum of pain relief scores from 0 to 4 hours (TOTPAR 0-4), from 4 to 8 hours (TOTPAR 4-8), and from 8 to 12 hours (TOTPAR 8-12): range of scores 0 (worst) to 16 (best). TOTPAR 0-12 range of scores 0 (worst) to 48 (best).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time-weighted Sum of Pain Relief Scores (TOTPAR) TOTPAR 0-4	1.91 units on a scale Standard Deviation 3.25	10.04 units on a scale Standard Deviation 3.66	9.90 units on a scale Standard Deviation 3.51	8.01 units on a scale Standard Deviation 3.96
Time-weighted Sum of Pain Relief Scores (TOTPAR) TOTPAR 4-8	3.38 units on a scale Standard Deviation 6.43	15.06 units on a scale Standard Deviation 4.76	15.02 units on a scale Standard Deviation 5.79	11.76 units on a scale Standard Deviation 6.35
Time-weighted Sum of Pain Relief Scores (TOTPAR) TOTPAR 8-12	3.03 units on a scale Standard Deviation 5.75	12.79 units on a scale Standard Deviation 5.97	13.59 units on a scale Standard Deviation 6.61	10.72 units on a scale Standard Deviation 6.89
Time-weighted Sum of Pain Relief Scores (TOTPAR) TOTPAR 0-12	7.04 units on a scale Standard Deviation 12.74	31.89 units on a scale Standard Deviation 10.67	32.67 units on a scale Standard Deviation 12.74	25.79 units on a scale Standard Deviation 13.48

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes

Population: ITT population

The elapsed time from dosing until the participant indicated first perceptible relief, provided the participant also indicated achieving meaningful relief. Perceptible relief defined as when participant first begins to feel any pain-relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she currently has now.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 30 minutes	3.4 percentage of participants	52.8 percentage of participants	55.4 percentage of participants	39.7 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 15 minutes	3.4 percentage of participants	17.0 percentage of participants	19.6 percentage of participants	8.6 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 45 minutes	6.9 percentage of participants	64.2 percentage of participants	73.2 percentage of participants	56.9 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 60 minutes	13.8 percentage of participants	81.1 percentage of participants	83.9 percentage of participants	65.5 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 90 minutes	13.8 percentage of participants	83.0 percentage of participants	87.5 percentage of participants	72.4 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 120 minutes	13.8 percentage of participants	83.0 percentage of participants	91.1 percentage of participants	72.4 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 180 minutes	13.8 percentage of participants	83.0 percentage of participants	91.1 percentage of participants	72.4 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 240 minutes	13.8 percentage of participants	83.0 percentage of participants	91.1 percentage of participants	72.4 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 300 minutes	13.8 percentage of participants	83.0 percentage of participants	91.1 percentage of participants	72.4 percentage of participants
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief 360 minutes	13.8 percentage of participants	83.0 percentage of participants	91.1 percentage of participants	72.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 6 hours

Population: ITT population

Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that is considered meaningful to the participant.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Time to Meaningful Pain Relief	NA minutes Median time to meaningful pain relief not achieved by more than 50 percent (%) of participants.	59.7 minutes Interval 52.3 to 88.3	76.7 minutes Interval 56.5 to 99.3	84.1 minutes Interval 63.8 to 174.2

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes

Population: ITT population

Participants evaluated the time to first perceptible pain relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief defined as relief from the pain that is considered meaningful to the participant.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Percentage of Participants Achieving Meaningful Pain Relief 300 minutes	10.3 percentage of participants	83.0 percentage of participants	91.1 percentage of participants	69.0 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 360 minutes	13.8 percentage of participants	83.0 percentage of participants	91.1 percentage of participants	72.4 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 15 minutes	0.0 percentage of participants	1.9 percentage of participants	0.0 percentage of participants	1.7 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 30 minutes	0.0 percentage of participants	9.4 percentage of participants	10.7 percentage of participants	3.4 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 45 minutes	3.4 percentage of participants	28.3 percentage of participants	28.6 percentage of participants	13.8 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 60 minutes	3.4 percentage of participants	50.9 percentage of participants	39.3 percentage of participants	31.0 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 90 minutes	3.4 percentage of participants	64.2 percentage of participants	57.1 percentage of participants	50.0 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 120 minutes	6.9 percentage of participants	71.7 percentage of participants	71.4 percentage of participants	56.9 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 180 minutes	10.3 percentage of participants	79.2 percentage of participants	82.1 percentage of participants	63.8 percentage of participants
Percentage of Participants Achieving Meaningful Pain Relief 240 minutes	10.3 percentage of participants	83.0 percentage of participants	89.3 percentage of participants	67.2 percentage of participants

SECONDARY outcome

Timeframe: 12 hours

Population: ITT population

Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Participant Global Evaluation of Study Medication at 12 Hours Very poor	20 participants	2 participants	2 participants	7 participants
Participant Global Evaluation of Study Medication at 12 Hours Poor	4 participants	1 participants	0 participants	1 participants
Participant Global Evaluation of Study Medication at 12 Hours Fair	1 participants	3 participants	4 participants	8 participants
Participant Global Evaluation of Study Medication at 12 Hours Good	2 participants	11 participants	9 participants	18 participants
Participant Global Evaluation of Study Medication at 12 Hours Very good	2 participants	20 participants	28 participants	15 participants
Participant Global Evaluation of Study Medication at 12 Hours Excellent	0 participants	16 participants	13 participants	9 participants

SECONDARY outcome

Timeframe: 24 hours

Population: ITT population; Number of participants analyzed (N)= participants with evaluable data

Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=52 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Participant Global Evaluation of Study Medication at 24 Hours Very poor	20 participants	2 participants	2 participants	7 participants
Participant Global Evaluation of Study Medication at 24 Hours Poor	4 participants	1 participants	0 participants	1 participants
Participant Global Evaluation of Study Medication at 24 Hours Fair	1 participants	2 participants	3 participants	4 participants
Participant Global Evaluation of Study Medication at 24 Hours Good	3 participants	14 participants	10 participants	17 participants
Participant Global Evaluation of Study Medication at 24 Hours Very good	1 participants	17 participants	23 participants	19 participants
Participant Global Evaluation of Study Medication at 24 Hours Excellent	0 participants	16 participants	18 participants	10 participants

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours

Population: ITT population.

PID based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). PID score derived by subtracting postdose score from baseline score and could range from -1 to 3. A baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated greater improvement (decrease in pain intensity).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Pain Intensity Difference (PID) Score 15 minutes	-0.14 units on a scale Standard Deviation 0.44	0.09 units on a scale Standard Deviation 0.45	0.09 units on a scale Standard Deviation 0.35	0.05 units on a scale Standard Deviation 0.22
Pain Intensity Difference (PID) Score 30 minutes	-0.14 units on a scale Standard Deviation 0.52	0.40 units on a scale Standard Deviation 0.69	0.34 units on a scale Standard Deviation 0.64	0.29 units on a scale Standard Deviation 0.53
Pain Intensity Difference (PID) Score 45 minutes	-0.10 units on a scale Standard Deviation 0.56	0.77 units on a scale Standard Deviation 0.89	0.70 units on a scale Standard Deviation 0.78	0.53 units on a scale Standard Deviation 0.60
Pain Intensity Difference (PID) Score 60 minutes	-0.10 units on a scale Standard Deviation 0.62	0.94 units on a scale Standard Deviation 0.99	1.00 units on a scale Standard Deviation 0.81	0.81 units on a scale Standard Deviation 0.76
Pain Intensity Difference (PID) Score 90 minutes	-0.07 units on a scale Standard Deviation 0.59	1.25 units on a scale Standard Deviation 1.02	1.29 units on a scale Standard Deviation 0.87	1.05 units on a scale Standard Deviation 0.80
Pain Intensity Difference (PID) Score 2 hours	0.00 units on a scale Standard Deviation 0.65	1.51 units on a scale Standard Deviation 0.97	1.48 units on a scale Standard Deviation 0.91	1.05 units on a scale Standard Deviation 0.83
Pain Intensity Difference (PID) Score 3 hours	0.00 units on a scale Standard Deviation 0.85	1.70 units on a scale Standard Deviation 0.97	1.64 units on a scale Standard Deviation 0.88	1.24 units on a scale Standard Deviation 0.94
Pain Intensity Difference (PID) Score 4 hours	0.03 units on a scale Standard Deviation 0.94	1.81 units on a scale Standard Deviation 0.92	1.66 units on a scale Standard Deviation 0.94	1.24 units on a scale Standard Deviation 0.98
Pain Intensity Difference (PID) Score 5 hours	0.07 units on a scale Standard Deviation 0.92	1.74 units on a scale Standard Deviation 0.94	1.68 units on a scale Standard Deviation 0.97	1.22 units on a scale Standard Deviation 1.04
Pain Intensity Difference (PID) Score 6 hours	0.07 units on a scale Standard Deviation 0.92	1.62 units on a scale Standard Deviation 0.99	1.66 units on a scale Standard Deviation 0.98	1.22 units on a scale Standard Deviation 1.04
Pain Intensity Difference (PID) Score 7 hours	0.07 units on a scale Standard Deviation 0.92	1.51 units on a scale Standard Deviation 0.97	1.64 units on a scale Standard Deviation 0.98	1.12 units on a scale Standard Deviation 1.01
Pain Intensity Difference (PID) Score 8 hours	0.07 units on a scale Standard Deviation 0.92	1.47 units on a scale Standard Deviation 0.91	1.48 units on a scale Standard Deviation 1.06	1.14 units on a scale Standard Deviation 1.00
Pain Intensity Difference (PID) Score 9 hours	0.00 units on a scale Standard Deviation 0.80	1.34 units on a scale Standard Deviation 0.94	1.41 units on a scale Standard Deviation 1.06	1.00 units on a scale Standard Deviation 1.03
Pain Intensity Difference (PID) Score 10 hours	-0.03 units on a scale Standard Deviation 0.78	1.26 units on a scale Standard Deviation 0.96	1.45 units on a scale Standard Deviation 1.11	1.02 units on a scale Standard Deviation 1.05
Pain Intensity Difference (PID) Score 11 hours	-0.03 units on a scale Standard Deviation 0.82	1.23 units on a scale Standard Deviation 0.97	1.43 units on a scale Standard Deviation 1.11	1.03 units on a scale Standard Deviation 1.11
Pain Intensity Difference (PID) Score 12 hours	-0.03 units on a scale Standard Deviation 0.82	1.26 units on a scale Standard Deviation 0.96	1.38 units on a scale Standard Deviation 1.09	0.95 units on a scale Standard Deviation 1.08
Pain Intensity Difference (PID) Score 13 hours	0.00 units on a scale Standard Deviation 0.85	1.25 units on a scale Standard Deviation 1.02	1.23 units on a scale Standard Deviation 1.14	0.95 units on a scale Standard Deviation 1.03
Pain Intensity Difference (PID) Score 14 hours	0.03 units on a scale Standard Deviation 0.91	1.15 units on a scale Standard Deviation 1.10	1.18 units on a scale Standard Deviation 1.15	0.93 units on a scale Standard Deviation 1.06
Pain Intensity Difference (PID) Score 16 hours	-0.03 units on a scale Standard Deviation 0.82	1.08 units on a scale Standard Deviation 1.05	1.02 units on a scale Standard Deviation 1.10	0.95 units on a scale Standard Deviation 1.07
Pain Intensity Difference (PID) Score 24 hours	0.07 units on a scale Standard Deviation 1.00	0.89 units on a scale Standard Deviation 1.01	0.91 units on a scale Standard Deviation 1.13	0.97 units on a scale Standard Deviation 1.08

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours

Population: ITT population.

PR score based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None \[0\], A Little \[1\], Some \[2\], A Lot \[3\] or Complete \[4\]. Higher scores indicated improvement (better pain relief).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Pain Relief (PR) Score 16 hours	0.59 units on a scale Standard Deviation 1.27	2.15 units on a scale Standard Deviation 1.47	2.00 units on a scale Standard Deviation 1.64	1.98 units on a scale Standard Deviation 1.57
Pain Relief (PR) Score 15 minutes	0.07 units on a scale Standard Deviation 0.26	0.36 units on a scale Standard Deviation 0.71	0.29 units on a scale Standard Deviation 0.56	0.28 units on a scale Standard Deviation 0.64
Pain Relief (PR) Score 30 minutes	0.21 units on a scale Standard Deviation 0.62	1.02 units on a scale Standard Deviation 0.99	0.82 units on a scale Standard Deviation 0.86	0.79 units on a scale Standard Deviation 0.91
Pain Relief (PR) Score 45 minutes	0.31 units on a scale Standard Deviation 0.66	1.72 units on a scale Standard Deviation 1.21	1.55 units on a scale Standard Deviation 1.17	1.21 units on a scale Standard Deviation 1.07
Pain Relief (PR) Score 60 minutes	0.41 units on a scale Standard Deviation 0.68	2.04 units on a scale Standard Deviation 1.27	1.98 units on a scale Standard Deviation 1.17	1.67 units on a scale Standard Deviation 1.19
Pain Relief (PR) Score 90 minutes	0.41 units on a scale Standard Deviation 0.73	2.40 units on a scale Standard Deviation 1.29	2.50 units on a scale Standard Deviation 1.16	2.09 units on a scale Standard Deviation 1.19
Pain Relief (PR) Score 2 hours	0.55 units on a scale Standard Deviation 0.91	2.66 units on a scale Standard Deviation 1.21	2.77 units on a scale Standard Deviation 1.14	2.24 units on a scale Standard Deviation 1.19
Pain Relief (PR) Score 3 hours	0.55 units on a scale Standard Deviation 1.15	3.06 units on a scale Standard Deviation 1.05	3.04 units on a scale Standard Deviation 1.09	2.43 units on a scale Standard Deviation 1.20
Pain Relief (PR) Score 4 hours	0.62 units on a scale Standard Deviation 1.27	3.17 units on a scale Standard Deviation 0.98	3.07 units on a scale Standard Deviation 1.13	2.43 units on a scale Standard Deviation 1.27
Pain Relief (PR) Score 5 hours	0.66 units on a scale Standard Deviation 1.29	3.13 units on a scale Standard Deviation 0.98	3.07 units on a scale Standard Deviation 1.19	2.36 units on a scale Standard Deviation 1.37
Pain Relief (PR) Score 6 hours	0.72 units on a scale Standard Deviation 1.36	2.98 units on a scale Standard Deviation 1.07	3.09 units on a scale Standard Deviation 1.16	2.40 units on a scale Standard Deviation 1.40
Pain Relief (PR) Score 7 hours	0.72 units on a scale Standard Deviation 1.36	2.94 units on a scale Standard Deviation 1.01	3.02 units on a scale Standard Deviation 1.20	2.29 units on a scale Standard Deviation 1.39
Pain Relief (PR) Score 8 hours	0.66 units on a scale Standard Deviation 1.26	2.83 units on a scale Standard Deviation 1.12	2.77 units on a scale Standard Deviation 1.33	2.28 units on a scale Standard Deviation 1.42
Pain Relief (PR) Score 9 hours	0.66 units on a scale Standard Deviation 1.23	2.55 units on a scale Standard Deviation 1.31	2.77 units on a scale Standard Deviation 1.32	2.16 units on a scale Standard Deviation 1.41
Pain Relief (PR) Score 10 hours	0.59 units on a scale Standard Deviation 1.15	2.51 units on a scale Standard Deviation 1.32	2.77 units on a scale Standard Deviation 1.36	2.14 units on a scale Standard Deviation 1.41
Pain Relief (PR) Score 11 hours	0.59 units on a scale Standard Deviation 1.21	2.47 units on a scale Standard Deviation 1.32	2.71 units on a scale Standard Deviation 1.37	2.17 units on a scale Standard Deviation 1.46
Pain Relief (PR) Score 12 hours	0.55 units on a scale Standard Deviation 1.18	2.43 units on a scale Standard Deviation 1.38	2.57 units on a scale Standard Deviation 1.45	1.98 units on a scale Standard Deviation 1.52
Pain Relief (PR) Score 13 hours	0.62 units on a scale Standard Deviation 1.27	2.43 units on a scale Standard Deviation 1.46	2.39 units on a scale Standard Deviation 1.53	2.03 units on a scale Standard Deviation 1.50
Pain Relief (PR) Score 14 hours	0.66 units on a scale Standard Deviation 1.34	2.28 units on a scale Standard Deviation 1.49	2.27 units on a scale Standard Deviation 1.60	2.03 units on a scale Standard Deviation 1.57
Pain Relief (PR) Score 24 hours	0.69 units on a scale Standard Deviation 1.42	1.92 units on a scale Standard Deviation 1.53	1.77 units on a scale Standard Deviation 1.71	2.00 units on a scale Standard Deviation 1.58

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours

Population: ITT population.

PRID=PID+PR, where PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline and could range from -1 to 3. Baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated improvement. PR: 5-point categorical pain relief scale (None \[0\], A Little \[1\], Some \[2\], A Lot \[3\], Complete \[4\]). PRID score could range from -1 to 7 where higher scores indicated better pain relief and decrease in pain intensity.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Pain Relief Combined With Pain Intensity Difference (PRID) Score 15 minutes	-0.07 units on a scale Standard Deviation 0.59	0.45 units on a scale Standard Deviation 1.08	0.38 units on a scale Standard Deviation 0.84	0.33 units on a scale Standard Deviation 0.80
Pain Relief Combined With Pain Intensity Difference (PRID) Score 30 minutes	0.07 units on a scale Standard Deviation 1.00	1.42 units on a scale Standard Deviation 1.60	1.16 units on a scale Standard Deviation 1.40	1.09 units on a scale Standard Deviation 1.37
Pain Relief Combined With Pain Intensity Difference (PRID) Score 45 minutes	0.21 units on a scale Standard Deviation 1.08	2.49 units on a scale Standard Deviation 2.04	2.25 units on a scale Standard Deviation 1.90	1.74 units on a scale Standard Deviation 1.58
Pain Relief Combined With Pain Intensity Difference (PRID) Score 60 minutes	0.31 units on a scale Standard Deviation 1.14	2.98 units on a scale Standard Deviation 2.18	2.98 units on a scale Standard Deviation 1.90	2.48 units on a scale Standard Deviation 1.86
Pain Relief Combined With Pain Intensity Difference (PRID) Score 90 minutes	0.34 units on a scale Standard Deviation 1.20	3.64 units on a scale Standard Deviation 2.22	3.79 units on a scale Standard Deviation 1.92	3.14 units on a scale Standard Deviation 1.88
Pain Relief Combined With Pain Intensity Difference (PRID) Score 2 hours	0.55 units on a scale Standard Deviation 1.45	4.17 units on a scale Standard Deviation 2.08	4.25 units on a scale Standard Deviation 1.97	3.29 units on a scale Standard Deviation 1.91
Pain Relief Combined With Pain Intensity Difference (PRID) Score 3 hours	0.55 units on a scale Standard Deviation 1.92	4.75 units on a scale Standard Deviation 1.94	4.68 units on a scale Standard Deviation 1.87	3.67 units on a scale Standard Deviation 2.03
Pain Relief Combined With Pain Intensity Difference (PRID) Score 4 hours	0.66 units on a scale Standard Deviation 2.13	4.98 units on a scale Standard Deviation 1.80	4.73 units on a scale Standard Deviation 1.97	3.67 units on a scale Standard Deviation 2.15
Pain Relief Combined With Pain Intensity Difference (PRID) Score 5 hours	0.72 units on a scale Standard Deviation 2.14	4.87 units on a scale Standard Deviation 1.83	4.75 units on a scale Standard Deviation 2.08	3.59 units on a scale Standard Deviation 2.32
Pain Relief Combined With Pain Intensity Difference (PRID) Score 6 hours	0.79 units on a scale Standard Deviation 2.21	4.60 units on a scale Standard Deviation 1.96	4.75 units on a scale Standard Deviation 2.06	3.62 units on a scale Standard Deviation 2.35
Pain Relief Combined With Pain Intensity Difference (PRID) Score 7 hours	0.79 units on a scale Standard Deviation 2.21	4.45 units on a scale Standard Deviation 1.90	4.66 units on a scale Standard Deviation 2.08	3.41 units on a scale Standard Deviation 2.32
Pain Relief Combined With Pain Intensity Difference (PRID) Score 8 hours	0.72 units on a scale Standard Deviation 2.10	4.30 units on a scale Standard Deviation 1.95	4.25 units on a scale Standard Deviation 2.30	3.41 units on a scale Standard Deviation 2.35
Pain Relief Combined With Pain Intensity Difference (PRID) Score 9 hours	0.66 units on a scale Standard Deviation 1.95	3.89 units on a scale Standard Deviation 2.14	4.18 units on a scale Standard Deviation 2.29	3.16 units on a scale Standard Deviation 2.36
Pain Relief Combined With Pain Intensity Difference (PRID) Score 10 hours	0.55 units on a scale Standard Deviation 1.82	3.77 units on a scale Standard Deviation 2.19	4.21 units on a scale Standard Deviation 2.38	3.16 units on a scale Standard Deviation 2.38
Pain Relief Combined With Pain Intensity Difference (PRID) Score 11 hours	0.55 units on a scale Standard Deviation 1.94	3.70 units on a scale Standard Deviation 2.22	4.14 units on a scale Standard Deviation 2.39	3.21 units on a scale Standard Deviation 2.50
Pain Relief Combined With Pain Intensity Difference (PRID) Score 12 hours	0.52 units on a scale Standard Deviation 1.92	3.70 units on a scale Standard Deviation 2.24	3.95 units on a scale Standard Deviation 2.45	2.93 units on a scale Standard Deviation 2.53
Pain Relief Combined With Pain Intensity Difference (PRID) Score 13 hours	0.62 units on a scale Standard Deviation 2.03	3.68 units on a scale Standard Deviation 2.39	3.63 units on a scale Standard Deviation 2.59	2.98 units on a scale Standard Deviation 2.46
Pain Relief Combined With Pain Intensity Difference (PRID) Score 14 hours	0.69 units on a scale Standard Deviation 2.17	3.43 units on a scale Standard Deviation 2.51	3.45 units on a scale Standard Deviation 2.68	2.97 units on a scale Standard Deviation 2.54
Pain Relief Combined With Pain Intensity Difference (PRID) Score 16 hours	0.55 units on a scale Standard Deviation 2.01	3.23 units on a scale Standard Deviation 2.43	3.02 units on a scale Standard Deviation 2.67	2.93 units on a scale Standard Deviation 2.57
Pain Relief Combined With Pain Intensity Difference (PRID) Score 24 hours	0.76 units on a scale Standard Deviation 2.34	2.81 units on a scale Standard Deviation 2.45	2.68 units on a scale Standard Deviation 2.78	2.97 units on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: Baseline to 12 hours

Population: ITT population

Maximum PR score over the scheduled pain relief assessments. PR score based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 Participants Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 Participants Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 Participants Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Peak Pain Relief Score	1.00 units on a scale Standard Deviation 1.41	3.42 units on a scale Standard Deviation 0.82	3.39 units on a scale Standard Deviation 0.85	3.05 units on a scale Standard Deviation 1.16

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Ibuprofen IR/ER (Roller Compaction)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ibuprofen IR/ER (Wet Granulation)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Naproxen

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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

Other adverse events
Measure	Placebo n=29 participants at risk Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery	Ibuprofen IR/ER (Roller Compaction) n=53 participants at risk Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery	Ibuprofen IR/ER (Wet Granulation) n=56 participants at risk Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery	Naproxen n=58 participants at risk Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
Eye disorders Eye swelling	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	20.7% 6/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	8.9% 5/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	3.4% 2/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	17.2% 5/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	5.4% 3/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Feeling hot	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Malaise	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.8% 1/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	3.4% 1/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	3.6% 2/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	3.4% 2/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	3.4% 1/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	3.8% 2/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.8% 1/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.8% 1/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxia	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.8% 1/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Pallor	0.00% 0/29 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/56 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.	1.7% 1/58 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.