Pain
Conditions
Keywords
Extended-release, ibuprofen
Brief summary
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.
Interventions
DRUGibuprofen
DRUGnaproxen
DRUGPlacebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
INCLUSION CRITERIA: * Males and females 16 to 40 years of age. * Outpatients who undergo surgical extraction of 1-2 third molars, one of which must be a partial or full bony mandibular impaction and have moderate to severe post-operative pain (confirmed by a VAS score of at least 50 mm on a 100 mm VAS) following surgical extraction; * Use of only the following preoperative medication(s)/anesthetic(s): short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, nitrous oxide, and/or midazolam; * Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form; * Examined by the attending dentist or physician and medically cleared to participate in the study; * In general good health and have no contraindications to the study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | Baseline (0 hour) to 12 hours post dose | 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). |
| Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | 8 to 12 hours post dose | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Failure | 8, 9, 10, 11, and 12 hours | Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy. |
| Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8) | 0 to 4 hours and 4 to 8 hours | 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). |
| Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours | 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. |
| Time-weighted Sum of Pain Relief Scores (TOTPAR) | 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours | 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). |
| Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes | 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. |
| Time to Meaningful Pain Relief | Baseline to 6 hours | 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. |
| Time to First Perceptible Pain Relief | Baseline to 6 hours | 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. |
| Participant Global Evaluation of Study Medication at 12 Hours | 12 hours | 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). |
| Participant Global Evaluation of Study Medication at 24 Hours | 24 hours | 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). |
| Pain Intensity Difference (PID) Score | 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours | 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). |
| Pain Relief (PR) Score | 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours | 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). |
| Pain Relief Combined With Pain Intensity Difference (PRID) Score | 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours | 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. |
| Peak Pain Relief Score | Baseline to 12 hours | 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). |
| Percentage of Participants Achieving Meaningful Pain Relief | 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes | 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. |
| Time to Treatment Failure | Baseline to 24 hours | Time to first rescue medication or discontinuation due to lack of efficacy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery | 29 |
| 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 | 53 |
| Ibuprofen IR/ER (Wet Granulation) Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery | 56 |
| Naproxen Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery | 58 |
| Total | 196 |
Baseline characteristics
| Characteristic | Placebo | Ibuprofen IR/ER (Roller Compaction) | Ibuprofen IR/ER (Wet Granulation) | Naproxen | Total |
|---|---|---|---|---|---|
| Age, Continuous | 18.1 years STANDARD_DEVIATION 2.1 | 18.6 years STANDARD_DEVIATION 2.4 | 18.7 years STANDARD_DEVIATION 2.7 | 18.3 years STANDARD_DEVIATION 2.6 | 18.5 years STANDARD_DEVIATION 2.5 |
| Pain intensity | 73.90 mm STANDARD_DEVIATION 11.6 | 77.06 mm STANDARD_DEVIATION 13.23 | 74.80 mm STANDARD_DEVIATION 12.4 | 75.12 mm STANDARD_DEVIATION 12.3 | 75.37 mm STANDARD_DEVIATION 12.44 |
| Pain severity Moderate | 18 participants | 29 participants | 33 participants | 34 participants | 114 participants |
| Pain severity Severe | 11 participants | 24 participants | 23 participants | 24 participants | 82 participants |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 23 Participants | 24 Participants | 81 Participants |
| Sex: Female, Male Male | 17 Participants | 31 Participants | 33 Participants | 34 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 29 | 3 / 53 | 8 / 56 | 6 / 58 |
| serious Total, serious adverse events | 0 / 29 | 0 / 53 | 0 / 56 | 0 / 58 |
Outcome results
Primary
Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | 16.87 units on a scale | Standard Deviation 9.35 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | 17.34 units on a scale | Standard Deviation 10.54 |
| Naproxen | Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | 12.66 units on a scale | Standard Deviation 10.02 |
p-value: <0.00195% CI: [12.13, 20.19]ANOVA
p-value: <0.00195% CI: [13.02, 20.99]ANOVA
p-value: <0.00195% CI: [8.33, 16.26]ANOVA
Primary
Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)
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).
Time frame: 8 to 12 hours post dose
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | 6.57 units on a scale | Standard Deviation 4.44 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | 7.14 units on a scale | Standard Deviation 5.24 |
| Naproxen | Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | 5.14 units on a scale | Standard Deviation 5.02 |
p-value: <0.00195% CI: [4.3, 8.38]ANOVA
p-value: <0.00195% CI: [5.05, 9.08]ANOVA
p-value: <0.00195% CI: [3.04, 7.06]ANOVA
Secondary
Pain Intensity Difference (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). 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Intensity Difference (PID) Score | 16 hours | -0.03 units on a scale | Standard Deviation 0.82 |
| Placebo | Pain Intensity Difference (PID) Score | 14 hours | 0.03 units on a scale | Standard Deviation 0.91 |
| Placebo | Pain Intensity Difference (PID) Score | 6 hours | 0.07 units on a scale | Standard Deviation 0.92 |
| Placebo | Pain Intensity Difference (PID) Score | 45 minutes | -0.10 units on a scale | Standard Deviation 0.56 |
| Placebo | Pain Intensity Difference (PID) Score | 13 hours | 0.00 units on a scale | Standard Deviation 0.85 |
| Placebo | Pain Intensity Difference (PID) Score | 12 hours | -0.03 units on a scale | Standard Deviation 0.82 |
| Placebo | Pain Intensity Difference (PID) Score | 15 minutes | -0.14 units on a scale | Standard Deviation 0.44 |
| Placebo | Pain Intensity Difference (PID) Score | 9 hours | 0.00 units on a scale | Standard Deviation 0.8 |
| Placebo | Pain Intensity Difference (PID) Score | 8 hours | 0.07 units on a scale | Standard Deviation 0.92 |
| Placebo | Pain Intensity Difference (PID) Score | 2 hours | 0.00 units on a scale | Standard Deviation 0.65 |
| Placebo | Pain Intensity Difference (PID) Score | 3 hours | 0.00 units on a scale | Standard Deviation 0.85 |
| Placebo | Pain Intensity Difference (PID) Score | 11 hours | -0.03 units on a scale | Standard Deviation 0.82 |
| Placebo | Pain Intensity Difference (PID) Score | 60 minutes | -0.10 units on a scale | Standard Deviation 0.62 |
| Placebo | Pain Intensity Difference (PID) Score | 10 hours | -0.03 units on a scale | Standard Deviation 0.78 |
| Placebo | Pain Intensity Difference (PID) Score | 7 hours | 0.07 units on a scale | Standard Deviation 0.92 |
| Placebo | Pain Intensity Difference (PID) Score | 4 hours | 0.03 units on a scale | Standard Deviation 0.94 |
| Placebo | Pain Intensity Difference (PID) Score | 90 minutes | -0.07 units on a scale | Standard Deviation 0.59 |
| Placebo | Pain Intensity Difference (PID) Score | 24 hours | 0.07 units on a scale | Standard Deviation 1 |
| Placebo | Pain Intensity Difference (PID) Score | 5 hours | 0.07 units on a scale | Standard Deviation 0.92 |
| Placebo | Pain Intensity Difference (PID) Score | 30 minutes | -0.14 units on a scale | Standard Deviation 0.52 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 10 hours | 1.26 units on a scale | Standard Deviation 0.96 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 30 minutes | 0.40 units on a scale | Standard Deviation 0.69 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 90 minutes | 1.25 units on a scale | Standard Deviation 1.02 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 2 hours | 1.51 units on a scale | Standard Deviation 0.97 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 3 hours | 1.70 units on a scale | Standard Deviation 0.97 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 4 hours | 1.81 units on a scale | Standard Deviation 0.92 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 5 hours | 1.74 units on a scale | Standard Deviation 0.94 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 6 hours | 1.62 units on a scale | Standard Deviation 0.99 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 7 hours | 1.51 units on a scale | Standard Deviation 0.97 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 8 hours | 1.47 units on a scale | Standard Deviation 0.91 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 9 hours | 1.34 units on a scale | Standard Deviation 0.94 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 12 hours | 1.26 units on a scale | Standard Deviation 0.96 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 13 hours | 1.25 units on a scale | Standard Deviation 1.02 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 14 hours | 1.15 units on a scale | Standard Deviation 1.1 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 16 hours | 1.08 units on a scale | Standard Deviation 1.05 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 24 hours | 0.89 units on a scale | Standard Deviation 1.01 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 11 hours | 1.23 units on a scale | Standard Deviation 0.97 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 15 minutes | 0.09 units on a scale | Standard Deviation 0.45 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 45 minutes | 0.77 units on a scale | Standard Deviation 0.89 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Intensity Difference (PID) Score | 60 minutes | 0.94 units on a scale | Standard Deviation 0.99 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 45 minutes | 0.70 units on a scale | Standard Deviation 0.78 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 6 hours | 1.66 units on a scale | Standard Deviation 0.98 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 13 hours | 1.23 units on a scale | Standard Deviation 1.14 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 14 hours | 1.18 units on a scale | Standard Deviation 1.15 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 5 hours | 1.68 units on a scale | Standard Deviation 0.97 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 60 minutes | 1.00 units on a scale | Standard Deviation 0.81 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 16 hours | 1.02 units on a scale | Standard Deviation 1.1 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 24 hours | 0.91 units on a scale | Standard Deviation 1.13 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 3 hours | 1.64 units on a scale | Standard Deviation 0.88 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 15 minutes | 0.09 units on a scale | Standard Deviation 0.35 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 10 hours | 1.45 units on a scale | Standard Deviation 1.11 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 2 hours | 1.48 units on a scale | Standard Deviation 0.91 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 11 hours | 1.43 units on a scale | Standard Deviation 1.11 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 30 minutes | 0.34 units on a scale | Standard Deviation 0.64 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 90 minutes | 1.29 units on a scale | Standard Deviation 0.87 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 8 hours | 1.48 units on a scale | Standard Deviation 1.06 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 7 hours | 1.64 units on a scale | Standard Deviation 0.98 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 4 hours | 1.66 units on a scale | Standard Deviation 0.94 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 9 hours | 1.41 units on a scale | Standard Deviation 1.06 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Intensity Difference (PID) Score | 12 hours | 1.38 units on a scale | Standard Deviation 1.09 |
| Naproxen | Pain Intensity Difference (PID) Score | 6 hours | 1.22 units on a scale | Standard Deviation 1.04 |
| Naproxen | Pain Intensity Difference (PID) Score | 10 hours | 1.02 units on a scale | Standard Deviation 1.05 |
| Naproxen | Pain Intensity Difference (PID) Score | 45 minutes | 0.53 units on a scale | Standard Deviation 0.6 |
| Naproxen | Pain Intensity Difference (PID) Score | 16 hours | 0.95 units on a scale | Standard Deviation 1.07 |
| Naproxen | Pain Intensity Difference (PID) Score | 13 hours | 0.95 units on a scale | Standard Deviation 1.03 |
| Naproxen | Pain Intensity Difference (PID) Score | 5 hours | 1.22 units on a scale | Standard Deviation 1.04 |
| Naproxen | Pain Intensity Difference (PID) Score | 4 hours | 1.24 units on a scale | Standard Deviation 0.98 |
| Naproxen | Pain Intensity Difference (PID) Score | 2 hours | 1.05 units on a scale | Standard Deviation 0.83 |
| Naproxen | Pain Intensity Difference (PID) Score | 14 hours | 0.93 units on a scale | Standard Deviation 1.06 |
| Naproxen | Pain Intensity Difference (PID) Score | 8 hours | 1.14 units on a scale | Standard Deviation 1 |
| Naproxen | Pain Intensity Difference (PID) Score | 90 minutes | 1.05 units on a scale | Standard Deviation 0.8 |
| Naproxen | Pain Intensity Difference (PID) Score | 15 minutes | 0.05 units on a scale | Standard Deviation 0.22 |
| Naproxen | Pain Intensity Difference (PID) Score | 12 hours | 0.95 units on a scale | Standard Deviation 1.08 |
| Naproxen | Pain Intensity Difference (PID) Score | 60 minutes | 0.81 units on a scale | Standard Deviation 0.76 |
| Naproxen | Pain Intensity Difference (PID) Score | 11 hours | 1.03 units on a scale | Standard Deviation 1.11 |
| Naproxen | Pain Intensity Difference (PID) Score | 24 hours | 0.97 units on a scale | Standard Deviation 1.08 |
| Naproxen | Pain Intensity Difference (PID) Score | 3 hours | 1.24 units on a scale | Standard Deviation 0.94 |
| Naproxen | Pain Intensity Difference (PID) Score | 9 hours | 1.00 units on a scale | Standard Deviation 1.03 |
| Naproxen | Pain Intensity Difference (PID) Score | 30 minutes | 0.29 units on a scale | Standard Deviation 0.53 |
| Naproxen | Pain Intensity Difference (PID) Score | 7 hours | 1.12 units on a scale | Standard Deviation 1.01 |
Comparison: 15 minutesp-value: 0.00895% CI: [0.06, 0.38]ANOVA
Comparison: 15 minutesp-value: 0.00795% CI: [0.06, 0.38]ANOVA
Comparison: 15 minutesp-value: 0.02495% CI: [0.02, 0.34]ANOVA
Comparison: 30 minutesp-value: <0.00195% CI: [0.24, 0.78]ANOVA
Comparison: 30 minutesp-value: <0.00195% CI: [0.2, 0.73]ANOVA
Comparison: 30 minutesp-value: 0.00295% CI: [0.16, 0.68]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [0.52, 1.17]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [0.47, 1.11]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [0.3, 0.94]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [0.65, 1.37]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [0.73, 1.44]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [0.54, 1.25]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [0.9, 1.63]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [0.97, 1.69]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [0.74, 1.45]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [1.09, 1.82]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [1.1, 1.82]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [0.67, 1.38]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [1.26, 2]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [1.25, 1.98]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [0.85, 1.57]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [1.33, 2.08]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [1.23, 1.97]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [0.81, 1.54]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [1.2, 2]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [1.19, 1.98]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [0.73, 1.52]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [1.08, 1.9]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [1.16, 1.97]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [0.72, 1.53]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [0.97, 1.79]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [1.14, 1.95]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [0.62, 1.43]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [0.93, 1.77]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [0.97, 1.81]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [0.63, 1.46]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [0.87, 1.71]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [0.97, 1.81]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [0.56, 1.39]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [0.82, 1.68]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [1.03, 1.89]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [0.6, 1.45]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [0.77, 1.64]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [0.42, 1.33]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [1, 1.87]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [0.61, 1.48]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [0.81, 1.68]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [0.96, 1.82]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [0.53, 1.39]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [0.75, 1.64]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [0.77, 1.65]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [0.49, 1.36]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [0.6, 1.53]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [0.66, 1.58]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [0.61, 1.51]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [0.58, 1.48]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [0.52, 1.4]ANOVA
Comparison: 24 hoursp-value: 0.00195% CI: [0.31, 1.24]ANOVA
Comparison: 24 hoursp-value: <0.00195% CI: [0.36, 1.28]ANOVA
Comparison: 24 hoursp-value: <0.00195% CI: [0.42, 1.33]ANOVA
Secondary
Pain Relief Combined With Pain Intensity Difference (PRID) Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 15 minutes | -0.07 units on a scale | Standard Deviation 0.59 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 30 minutes | 0.07 units on a scale | Standard Deviation 1 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 45 minutes | 0.21 units on a scale | Standard Deviation 1.08 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 60 minutes | 0.31 units on a scale | Standard Deviation 1.14 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 90 minutes | 0.34 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 2 hours | 0.55 units on a scale | Standard Deviation 1.45 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 3 hours | 0.55 units on a scale | Standard Deviation 1.92 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 4 hours | 0.66 units on a scale | Standard Deviation 2.13 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 5 hours | 0.72 units on a scale | Standard Deviation 2.14 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 6 hours | 0.79 units on a scale | Standard Deviation 2.21 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 7 hours | 0.79 units on a scale | Standard Deviation 2.21 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 8 hours | 0.72 units on a scale | Standard Deviation 2.1 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 10 hours | 0.55 units on a scale | Standard Deviation 1.82 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 13 hours | 0.62 units on a scale | Standard Deviation 2.03 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 14 hours | 0.69 units on a scale | Standard Deviation 2.17 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 16 hours | 0.55 units on a scale | Standard Deviation 2.01 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 24 hours | 0.76 units on a scale | Standard Deviation 2.34 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 9 hours | 0.66 units on a scale | Standard Deviation 1.95 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 11 hours | 0.55 units on a scale | Standard Deviation 1.94 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 12 hours | 0.52 units on a scale | Standard Deviation 1.92 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 9 hours | 3.89 units on a scale | Standard Deviation 2.14 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 8 hours | 4.30 units on a scale | Standard Deviation 1.95 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 24 hours | 2.81 units on a scale | Standard Deviation 2.45 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 2 hours | 4.17 units on a scale | Standard Deviation 2.08 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 11 hours | 3.70 units on a scale | Standard Deviation 2.22 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 3 hours | 4.75 units on a scale | Standard Deviation 1.94 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 10 hours | 3.77 units on a scale | Standard Deviation 2.19 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 13 hours | 3.68 units on a scale | Standard Deviation 2.39 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 5 hours | 4.87 units on a scale | Standard Deviation 1.83 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 12 hours | 3.70 units on a scale | Standard Deviation 2.24 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 60 minutes | 2.98 units on a scale | Standard Deviation 2.18 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 45 minutes | 2.49 units on a scale | Standard Deviation 2.04 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 30 minutes | 1.42 units on a scale | Standard Deviation 1.6 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 6 hours | 4.60 units on a scale | Standard Deviation 1.96 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 90 minutes | 3.64 units on a scale | Standard Deviation 2.22 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 15 minutes | 0.45 units on a scale | Standard Deviation 1.08 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 16 hours | 3.23 units on a scale | Standard Deviation 2.43 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 7 hours | 4.45 units on a scale | Standard Deviation 1.9 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 4 hours | 4.98 units on a scale | Standard Deviation 1.8 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 14 hours | 3.43 units on a scale | Standard Deviation 2.51 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 9 hours | 4.18 units on a scale | Standard Deviation 2.29 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 2 hours | 4.25 units on a scale | Standard Deviation 1.97 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 3 hours | 4.68 units on a scale | Standard Deviation 1.87 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 4 hours | 4.73 units on a scale | Standard Deviation 1.97 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 5 hours | 4.75 units on a scale | Standard Deviation 2.08 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 6 hours | 4.75 units on a scale | Standard Deviation 2.06 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 7 hours | 4.66 units on a scale | Standard Deviation 2.08 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 8 hours | 4.25 units on a scale | Standard Deviation 2.3 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 10 hours | 4.21 units on a scale | Standard Deviation 2.38 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 12 hours | 3.95 units on a scale | Standard Deviation 2.45 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 13 hours | 3.63 units on a scale | Standard Deviation 2.59 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 14 hours | 3.45 units on a scale | Standard Deviation 2.68 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 11 hours | 4.14 units on a scale | Standard Deviation 2.39 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 16 hours | 3.02 units on a scale | Standard Deviation 2.67 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 15 minutes | 0.38 units on a scale | Standard Deviation 0.84 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 30 minutes | 1.16 units on a scale | Standard Deviation 1.4 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 45 minutes | 2.25 units on a scale | Standard Deviation 1.9 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 60 minutes | 2.98 units on a scale | Standard Deviation 1.9 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 24 hours | 2.68 units on a scale | Standard Deviation 2.78 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 90 minutes | 3.79 units on a scale | Standard Deviation 1.92 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 3 hours | 3.67 units on a scale | Standard Deviation 2.03 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 6 hours | 3.62 units on a scale | Standard Deviation 2.35 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 2 hours | 3.29 units on a scale | Standard Deviation 1.91 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 15 minutes | 0.33 units on a scale | Standard Deviation 0.8 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 16 hours | 2.93 units on a scale | Standard Deviation 2.57 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 8 hours | 3.41 units on a scale | Standard Deviation 2.35 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 60 minutes | 2.48 units on a scale | Standard Deviation 1.86 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 30 minutes | 1.09 units on a scale | Standard Deviation 1.37 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 11 hours | 3.21 units on a scale | Standard Deviation 2.5 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 5 hours | 3.59 units on a scale | Standard Deviation 2.32 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 12 hours | 2.93 units on a scale | Standard Deviation 2.53 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 10 hours | 3.16 units on a scale | Standard Deviation 2.38 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 90 minutes | 3.14 units on a scale | Standard Deviation 1.88 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 13 hours | 2.98 units on a scale | Standard Deviation 2.46 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 9 hours | 3.16 units on a scale | Standard Deviation 2.36 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 7 hours | 3.41 units on a scale | Standard Deviation 2.32 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 45 minutes | 1.74 units on a scale | Standard Deviation 1.58 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 14 hours | 2.97 units on a scale | Standard Deviation 2.54 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 4 hours | 3.67 units on a scale | Standard Deviation 2.15 |
| Naproxen | Pain Relief Combined With Pain Intensity Difference (PRID) Score | 24 hours | 2.97 units on a scale | Standard Deviation 2.58 |
Comparison: 15 minutesp-value: 0.01195% CI: [0.12, 0.91]ANOVA
Comparison: 15 minutesp-value: 0.02895% CI: [0.05, 0.83]ANOVA
Comparison: 15 minutesp-value: 0.04895% CI: [0, 0.78]ANOVA
Comparison: 30 minutesp-value: <0.00195% CI: [0.69, 1.96]ANOVA
Comparison: 30 minutesp-value: <0.00195% CI: [0.45, 1.71]ANOVA
Comparison: 30 minutesp-value: 0.00295% CI: [0.38, 1.63]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [1.46, 3.06]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [1.24, 2.82]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [0.74, 2.31]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [2.57, 4.28]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [1.92, 3.63]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [2.7, 4.44]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [1.78, 3.5]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [1.81, 3.51]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [1.32, 3]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [2.39, 4.12]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [2.82, 4.53]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [1.87, 3.57]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [3.27, 4.99]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [2.78, 4.71]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [3.24, 4.95]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [2.24, 3.93]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [3.36, 5.13]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [3.17, 4.92]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [2.11, 3.85]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [3.14, 5.01]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [3.07, 4.92]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [1.91, 3.75]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [2.98, 4.89]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [1.85, 3.75]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [2.65, 4.56]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [2.89, 4.79]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [1.65, 3.54]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [2.54, 4.53]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [2.52, 4.49]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [1.69, 3.65]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [2.19, 4.21]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [2.51, 4.51]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [1.49, 3.48]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [2.17, 4.21]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [2.64, 4.66]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [1.58, 3.6]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [2.06, 4.15]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [2.53, 4.61]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [1.61, 3.67]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [2.09, 4.21]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [2.36, 4.46]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [1.36, 3.44]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [1.94, 4.12]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [1.91, 4.07]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [1.28, 3.42]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [1.57, 3.83]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [1.62, 3.85]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [1.14, 3.37]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [1.51, 3.76]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [1.33, 3.56]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [1.25, 3.47]ANOVA
Comparison: 24 hoursp-value: <0.00195% CI: [0.86, 3.19]ANOVA
Comparison: 24 hoursp-value: 0.00195% CI: [0.75, 3.05]ANOVA
Comparison: 24 hoursp-value: <0.00195% CI: [1.05, 3.34]ANOVA
Secondary
Pain Relief (PR) Score
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Relief (PR) Score | 45 minutes | 0.31 units on a scale | Standard Deviation 0.66 |
| Placebo | Pain Relief (PR) Score | 14 hours | 0.66 units on a scale | Standard Deviation 1.34 |
| Placebo | Pain Relief (PR) Score | 10 hours | 0.59 units on a scale | Standard Deviation 1.15 |
| Placebo | Pain Relief (PR) Score | 11 hours | 0.59 units on a scale | Standard Deviation 1.21 |
| Placebo | Pain Relief (PR) Score | 15 minutes | 0.07 units on a scale | Standard Deviation 0.26 |
| Placebo | Pain Relief (PR) Score | 12 hours | 0.55 units on a scale | Standard Deviation 1.18 |
| Placebo | Pain Relief (PR) Score | 13 hours | 0.62 units on a scale | Standard Deviation 1.27 |
| Placebo | Pain Relief (PR) Score | 2 hours | 0.55 units on a scale | Standard Deviation 0.91 |
| Placebo | Pain Relief (PR) Score | 3 hours | 0.55 units on a scale | Standard Deviation 1.15 |
| Placebo | Pain Relief (PR) Score | 90 minutes | 0.41 units on a scale | Standard Deviation 0.73 |
| Placebo | Pain Relief (PR) Score | 4 hours | 0.62 units on a scale | Standard Deviation 1.27 |
| Placebo | Pain Relief (PR) Score | 30 minutes | 0.21 units on a scale | Standard Deviation 0.62 |
| Placebo | Pain Relief (PR) Score | 5 hours | 0.66 units on a scale | Standard Deviation 1.29 |
| Placebo | Pain Relief (PR) Score | 60 minutes | 0.41 units on a scale | Standard Deviation 0.68 |
| Placebo | Pain Relief (PR) Score | 6 hours | 0.72 units on a scale | Standard Deviation 1.36 |
| Placebo | Pain Relief (PR) Score | 7 hours | 0.72 units on a scale | Standard Deviation 1.36 |
| Placebo | Pain Relief (PR) Score | 24 hours | 0.69 units on a scale | Standard Deviation 1.42 |
| Placebo | Pain Relief (PR) Score | 8 hours | 0.66 units on a scale | Standard Deviation 1.26 |
| Placebo | Pain Relief (PR) Score | 16 hours | 0.59 units on a scale | Standard Deviation 1.27 |
| Placebo | Pain Relief (PR) Score | 9 hours | 0.66 units on a scale | Standard Deviation 1.23 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 16 hours | 2.15 units on a scale | Standard Deviation 1.47 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 4 hours | 3.17 units on a scale | Standard Deviation 0.98 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 8 hours | 2.83 units on a scale | Standard Deviation 1.12 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 10 hours | 2.51 units on a scale | Standard Deviation 1.32 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 45 minutes | 1.72 units on a scale | Standard Deviation 1.21 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 60 minutes | 2.04 units on a scale | Standard Deviation 1.27 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 11 hours | 2.47 units on a scale | Standard Deviation 1.32 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 7 hours | 2.94 units on a scale | Standard Deviation 1.01 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 13 hours | 2.43 units on a scale | Standard Deviation 1.46 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 5 hours | 3.13 units on a scale | Standard Deviation 0.98 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 12 hours | 2.43 units on a scale | Standard Deviation 1.38 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 90 minutes | 2.40 units on a scale | Standard Deviation 1.29 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 14 hours | 2.28 units on a scale | Standard Deviation 1.49 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 30 minutes | 1.02 units on a scale | Standard Deviation 0.99 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 6 hours | 2.98 units on a scale | Standard Deviation 1.07 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 2 hours | 2.66 units on a scale | Standard Deviation 1.21 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 9 hours | 2.55 units on a scale | Standard Deviation 1.31 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 3 hours | 3.06 units on a scale | Standard Deviation 1.05 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 24 hours | 1.92 units on a scale | Standard Deviation 1.53 |
| Ibuprofen IR/ER (Roller Compaction) | Pain Relief (PR) Score | 15 minutes | 0.36 units on a scale | Standard Deviation 0.71 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 60 minutes | 1.98 units on a scale | Standard Deviation 1.17 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 15 minutes | 0.29 units on a scale | Standard Deviation 0.56 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 30 minutes | 0.82 units on a scale | Standard Deviation 0.86 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 45 minutes | 1.55 units on a scale | Standard Deviation 1.17 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 3 hours | 3.04 units on a scale | Standard Deviation 1.09 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 4 hours | 3.07 units on a scale | Standard Deviation 1.13 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 5 hours | 3.07 units on a scale | Standard Deviation 1.19 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 6 hours | 3.09 units on a scale | Standard Deviation 1.16 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 7 hours | 3.02 units on a scale | Standard Deviation 1.2 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 8 hours | 2.77 units on a scale | Standard Deviation 1.33 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 9 hours | 2.77 units on a scale | Standard Deviation 1.32 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 10 hours | 2.77 units on a scale | Standard Deviation 1.36 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 11 hours | 2.71 units on a scale | Standard Deviation 1.37 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 12 hours | 2.57 units on a scale | Standard Deviation 1.45 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 13 hours | 2.39 units on a scale | Standard Deviation 1.53 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 14 hours | 2.27 units on a scale | Standard Deviation 1.6 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 16 hours | 2.00 units on a scale | Standard Deviation 1.64 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 24 hours | 1.77 units on a scale | Standard Deviation 1.71 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 90 minutes | 2.50 units on a scale | Standard Deviation 1.16 |
| Ibuprofen IR/ER (Wet Granulation) | Pain Relief (PR) Score | 2 hours | 2.77 units on a scale | Standard Deviation 1.14 |
| Naproxen | Pain Relief (PR) Score | 8 hours | 2.28 units on a scale | Standard Deviation 1.42 |
| Naproxen | Pain Relief (PR) Score | 6 hours | 2.40 units on a scale | Standard Deviation 1.4 |
| Naproxen | Pain Relief (PR) Score | 10 hours | 2.14 units on a scale | Standard Deviation 1.41 |
| Naproxen | Pain Relief (PR) Score | 16 hours | 1.98 units on a scale | Standard Deviation 1.57 |
| Naproxen | Pain Relief (PR) Score | 12 hours | 1.98 units on a scale | Standard Deviation 1.52 |
| Naproxen | Pain Relief (PR) Score | 24 hours | 2.00 units on a scale | Standard Deviation 1.58 |
| Naproxen | Pain Relief (PR) Score | 45 minutes | 1.21 units on a scale | Standard Deviation 1.07 |
| Naproxen | Pain Relief (PR) Score | 5 hours | 2.36 units on a scale | Standard Deviation 1.37 |
| Naproxen | Pain Relief (PR) Score | 4 hours | 2.43 units on a scale | Standard Deviation 1.27 |
| Naproxen | Pain Relief (PR) Score | 3 hours | 2.43 units on a scale | Standard Deviation 1.2 |
| Naproxen | Pain Relief (PR) Score | 60 minutes | 1.67 units on a scale | Standard Deviation 1.19 |
| Naproxen | Pain Relief (PR) Score | 90 minutes | 2.09 units on a scale | Standard Deviation 1.19 |
| Naproxen | Pain Relief (PR) Score | 30 minutes | 0.79 units on a scale | Standard Deviation 0.91 |
| Naproxen | Pain Relief (PR) Score | 15 minutes | 0.28 units on a scale | Standard Deviation 0.64 |
| Naproxen | Pain Relief (PR) Score | 11 hours | 2.17 units on a scale | Standard Deviation 1.46 |
| Naproxen | Pain Relief (PR) Score | 2 hours | 2.24 units on a scale | Standard Deviation 1.19 |
| Naproxen | Pain Relief (PR) Score | 13 hours | 2.03 units on a scale | Standard Deviation 1.5 |
| Naproxen | Pain Relief (PR) Score | 9 hours | 2.16 units on a scale | Standard Deviation 1.41 |
| Naproxen | Pain Relief (PR) Score | 7 hours | 2.29 units on a scale | Standard Deviation 1.39 |
| Naproxen | Pain Relief (PR) Score | 14 hours | 2.03 units on a scale | Standard Deviation 1.57 |
Comparison: 15 minutesp-value: 0.03495% CI: [0.02, 0.57]ANOVA
Comparison: 15 minutesp-value: 0.11195% CI: [-0.05, 0.49]ANOVA
Comparison: 15 minutesp-value: 0.12595% CI: [-0.06, 0.48]ANOVA
Comparison: 30 minutesp-value: <0.00195% CI: [0.41, 1.22]ANOVA
Comparison: 30 minutesp-value: 0.00395% CI: [0.22, 1.01]ANOVA
Comparison: 30 minutesp-value: 0.00495% CI: [0.19, 0.98]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [0.91, 1.91]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [0.75, 1.74]ANOVA
Comparison: 45 minutesp-value: <0.00195% CI: [0.41, 1.39]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [1.11, 2.16]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [1.05, 2.09]ANOVA
Comparison: 60 minutesp-value: <0.00195% CI: [0.75, 1.78]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [1.46, 2.52]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [1.57, 2.61]ANOVA
Comparison: 90 minutesp-value: <0.00195% CI: [1.16, 2.2]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [1.59, 2.64]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [1.7, 2.74]ANOVA
Comparison: 2 hoursp-value: <0.00195% CI: [1.18, 2.21]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [1.98, 3.01]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [1.97, 2.99]ANOVA
Comparison: 3 hoursp-value: <0.00195% CI: [1.37, 2.38]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [2.01, 3.07]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [1.92, 2.97]ANOVA
Comparison: 4 hoursp-value: <0.00195% CI: [1.29, 2.33]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [1.92, 3.03]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [0.73, 2.1]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [1.87, 2.96]ANOVA
Comparison: 5 hoursp-value: <0.00195% CI: [1.16, 2.25]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [1.69, 2.83]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [1.8, 2.93]ANOVA
Comparison: 6 hoursp-value: <0.00195% CI: [1.11, 2.23]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [1.66, 2.79]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [1.74, 2.85]ANOVA
Comparison: 7 hoursp-value: <0.00195% CI: [1.02, 2.13]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [1.59, 2.78]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [1.53, 2.7]ANOVA
Comparison: 8 hoursp-value: <0.00195% CI: [1.04, 2.21]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [1.3, 2.52]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [1.52, 2.72]ANOVA
Comparison: 9 hoursp-value: <0.00195% CI: [0.91, 2.11]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [1.34, 2.55]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [1.59, 2.79]ANOVA
Comparison: 10 hoursp-value: <0.00195% CI: [0.97, 2.16]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [1.28, 2.52]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [1.52, 2.75]ANOVA
Comparison: 11 hoursp-value: <0.00195% CI: [0.98, 2.2]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [1.26, 2.54]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [1.39, 2.66]ANOVA
Comparison: 12 hoursp-value: <0.00195% CI: [0.81, 2.07]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [1.17, 2.49]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [1.13, 2.43]ANOVA
Comparison: 13 hoursp-value: <0.00195% CI: [0.78, 2.07]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [0.95, 2.32]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [0.94, 2.29]ANOVA
Comparison: 14 hoursp-value: <0.00195% CI: [0.71, 2.06]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [0.88, 2.27]ANOVA
Comparison: 16 hoursp-value: <0.00195% CI: [0.72, 2.08]ANOVA
Comparison: 24 hoursp-value: <0.00195% CI: [0.53, 1.96]ANOVA
Comparison: 24 hoursp-value: 0.00395% CI: [0.38, 1.79]ANOVA
Comparison: 24 hoursp-value: <0.00195% CI: [0.61, 2.02]ANOVA
Secondary
Participant Global Evaluation of Study Medication at 12 Hours
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).
Time frame: 12 hours
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Participant Global Evaluation of Study Medication at 12 Hours | Fair | 1 participants |
| Placebo | Participant Global Evaluation of Study Medication at 12 Hours | Good | 2 participants |
| Placebo | Participant Global Evaluation of Study Medication at 12 Hours | Very good | 2 participants |
| Placebo | Participant Global Evaluation of Study Medication at 12 Hours | Excellent | 0 participants |
| Placebo | Participant Global Evaluation of Study Medication at 12 Hours | Poor | 4 participants |
| Placebo | Participant Global Evaluation of Study Medication at 12 Hours | Very poor | 20 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 12 Hours | Fair | 3 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 12 Hours | Very good | 20 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 12 Hours | Good | 11 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 12 Hours | Very poor | 2 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 12 Hours | Poor | 1 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 12 Hours | Excellent | 16 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 12 Hours | Fair | 4 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 12 Hours | Very good | 28 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 12 Hours | Very poor | 2 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 12 Hours | Poor | 0 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 12 Hours | Good | 9 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 12 Hours | Excellent | 13 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 12 Hours | Poor | 1 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 12 Hours | Very good | 15 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 12 Hours | Very poor | 7 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 12 Hours | Fair | 8 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 12 Hours | Excellent | 9 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 12 Hours | Good | 18 participants |
p-value: <0.00195% CI: [0.85, 1.01]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [0.88, 1.02]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [0.7, 0.98]Cochran-Mantel-Haenszel
Secondary
Participant Global Evaluation of Study Medication at 24 Hours
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).
Time frame: 24 hours
Population: ITT population; Number of participants analyzed (N)= participants with evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Participant Global Evaluation of Study Medication at 24 Hours | Fair | 1 participants |
| Placebo | Participant Global Evaluation of Study Medication at 24 Hours | Very good | 1 participants |
| Placebo | Participant Global Evaluation of Study Medication at 24 Hours | Excellent | 0 participants |
| Placebo | Participant Global Evaluation of Study Medication at 24 Hours | Good | 3 participants |
| Placebo | Participant Global Evaluation of Study Medication at 24 Hours | Very poor | 20 participants |
| Placebo | Participant Global Evaluation of Study Medication at 24 Hours | Poor | 4 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 24 Hours | Very poor | 2 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 24 Hours | Poor | 1 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 24 Hours | Very good | 17 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 24 Hours | Good | 14 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 24 Hours | Fair | 2 participants |
| Ibuprofen IR/ER (Roller Compaction) | Participant Global Evaluation of Study Medication at 24 Hours | Excellent | 16 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 24 Hours | Very poor | 2 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 24 Hours | Good | 10 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 24 Hours | Very good | 23 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 24 Hours | Excellent | 18 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 24 Hours | Poor | 0 participants |
| Ibuprofen IR/ER (Wet Granulation) | Participant Global Evaluation of Study Medication at 24 Hours | Fair | 3 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 24 Hours | Very poor | 7 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 24 Hours | Very good | 19 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 24 Hours | Excellent | 10 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 24 Hours | Fair | 4 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 24 Hours | Good | 17 participants |
| Naproxen | Participant Global Evaluation of Study Medication at 24 Hours | Poor | 1 participants |
p-value: <0.00195% CI: [0.85, 1.01]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [0.91, 1.01]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [0.79, 0.99]Cochran-Mantel-Haenszel
Secondary
Peak Pain Relief Score
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).
Time frame: Baseline to 12 hours
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Peak Pain Relief Score | 1.00 units on a scale | Standard Deviation 1.41 |
| Ibuprofen IR/ER (Roller Compaction) | Peak Pain Relief Score | 3.42 units on a scale | Standard Deviation 0.82 |
| Ibuprofen IR/ER (Wet Granulation) | Peak Pain Relief Score | 3.39 units on a scale | Standard Deviation 0.85 |
| Naproxen | Peak Pain Relief Score | 3.05 units on a scale | Standard Deviation 1.16 |
p-value: <0.00195% CI: [1.94, 2.89]ANOVA
p-value: <0.00195% CI: [1.92, 2.86]ANOVA
p-value: <0.00195% CI: [1.58, 2.52]ANOVA
Secondary
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief
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.
Time frame: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 300 minutes | 13.8 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 120 minutes | 13.8 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 240 minutes | 13.8 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 180 minutes | 13.8 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 45 minutes | 6.9 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 15 minutes | 3.4 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 360 minutes | 13.8 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 60 minutes | 13.8 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 30 minutes | 3.4 percentage of participants |
| Placebo | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 90 minutes | 13.8 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 300 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 240 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 120 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 15 minutes | 17.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 90 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 60 minutes | 81.1 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 180 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 360 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 30 minutes | 52.8 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 45 minutes | 64.2 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 360 minutes | 91.1 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 15 minutes | 19.6 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 30 minutes | 55.4 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 45 minutes | 73.2 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 60 minutes | 83.9 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 90 minutes | 87.5 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 120 minutes | 91.1 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 180 minutes | 91.1 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 240 minutes | 91.1 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 300 minutes | 91.1 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 90 minutes | 72.4 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 30 minutes | 39.7 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 240 minutes | 72.4 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 360 minutes | 72.4 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 60 minutes | 65.5 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 15 minutes | 8.6 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 300 minutes | 72.4 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 45 minutes | 56.9 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 180 minutes | 72.4 percentage of participants |
| Naproxen | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 120 minutes | 72.4 percentage of participants |
Comparison: 15 minutesp-value: 0.0895% CI: [1.26, 25.36]Cochran-Mantel-Haenszel
Comparison: 15 minutesp-value: 0.04395% CI: [3.73, 29.04]Cochran-Mantel-Haenszel
Comparison: 15 minutesp-value: 0.35495% CI: [-4.62, 15.4]Cochran-Mantel-Haenszel
Comparison: 30 minutesp-value: <0.00195% CI: [33.34, 63.96]Cochran-Mantel-Haenszel
Comparison: 30 minutesp-value: <0.00195% CI: [37.15, 66.73]Cochran-Mantel-Haenszel
Comparison: 30 minutesp-value: <0.00195% CI: [22.62, 50.98]Cochran-Mantel-Haenszel
Comparison: 45 minutesp-value: <0.00195% CI: [41.2, 73.57]Cochran-Mantel-Haenszel
Comparison: 45 minutesp-value: <0.00195% CI: [51.56, 81.78]Cochran-Mantel-Haenszel
Comparison: 45 minutesp-value: <0.00195% CI: [34.2, 66.21]Cochran-Mantel-Haenszel
Comparison: 60 minutesp-value: <0.00195% CI: [51.36, 83.93]Cochran-Mantel-Haenszel
Comparison: 60 minutesp-value: <0.00195% CI: [55.16, 86.05]Cochran-Mantel-Haenszel
Comparison: 60 minutesp-value: <0.00195% CI: [34.32, 69.38]Cochran-Mantel-Haenszel
Comparison: 90 minutesp-value: <0.00195% CI: [53.33, 85.33]Cochran-Mantel-Haenszel
Comparison: 90 minutesp-value: <0.00195% CI: [59.29, 89.14]Cochran-Mantel-Haenszel
Comparison: 90 minutesp-value: <0.00195% CI: [41.88, 75.84]Cochran-Mantel-Haenszel
Comparison: 120 minutesp-value: <0.00195% CI: [53.33, 85.33]Cochran-Mantel-Haenszel
Comparison: 120 minutesp-value: <0.00195% CI: [63.57, 92.06]Cochran-Mantel-Haenszel
Comparison: 120 minutesp-value: <0.00195% CI: [41.88, 75.84]Cochran-Mantel-Haenszel
Comparison: 180 minutesp-value: <0.00195% CI: [53.33, 85.33]Cochran-Mantel-Haenszel
Comparison: 180 minutesp-value: <0.00195% CI: [63.57, 92.06]Cochran-Mantel-Haenszel
Comparison: 180 minutesp-value: <0.00195% CI: [41.88, 75.84]Cochran-Mantel-Haenszel
Comparison: 240 minutesp-value: <0.00195% CI: [53.33, 85.33]Cochran-Mantel-Haenszel
Comparison: 240 minutesp-value: <0.00195% CI: [63.57, 92.06]Cochran-Mantel-Haenszel
Comparison: 240 minutesp-value: <0.00195% CI: [41.88, 75.84]Cochran-Mantel-Haenszel
Comparison: 300 minutesp-value: <0.00195% CI: [53.33, 85.33]Cochran-Mantel-Haenszel
Comparison: 300 minutesp-value: <0.00195% CI: [63.57, 92.06]Cochran-Mantel-Haenszel
Comparison: 300 minutesp-value: <0.00195% CI: [41.88, 75.84]Cochran-Mantel-Haenszel
Comparison: 360 minutesp-value: <0.00195% CI: [53.33, 85.33]Cochran-Mantel-Haenszel
Comparison: 360 minutesp-value: <0.00195% CI: [63.57, 92.06]Cochran-Mantel-Haenszel
Comparison: 360 minutesp-value: <0.00195% CI: [41.88, 75.84]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Meaningful Pain Relief
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.
Time frame: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 240 minutes | 10.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 45 minutes | 3.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 30 minutes | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 360 minutes | 13.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 90 minutes | 3.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 60 minutes | 3.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 180 minutes | 10.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 300 minutes | 10.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 120 minutes | 6.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Meaningful Pain Relief | 15 minutes | 0.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 120 minutes | 71.7 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 240 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 180 minutes | 79.2 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 45 minutes | 28.3 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 360 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 60 minutes | 50.9 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 90 minutes | 64.2 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 30 minutes | 9.4 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 300 minutes | 83.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants Achieving Meaningful Pain Relief | 15 minutes | 1.9 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 360 minutes | 91.1 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 15 minutes | 0.0 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 30 minutes | 10.7 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 45 minutes | 28.6 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 60 minutes | 39.3 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 90 minutes | 57.1 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 120 minutes | 71.4 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 240 minutes | 89.3 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 180 minutes | 82.1 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants Achieving Meaningful Pain Relief | 300 minutes | 91.1 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 45 minutes | 13.8 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 180 minutes | 63.8 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 360 minutes | 72.4 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 240 minutes | 67.2 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 90 minutes | 50.0 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 15 minutes | 1.7 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 300 minutes | 69.0 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 60 minutes | 31.0 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 120 minutes | 56.9 percentage of participants |
| Naproxen | Percentage of Participants Achieving Meaningful Pain Relief | 30 minutes | 3.4 percentage of participants |
Comparison: 15 minutesp-value: 0.43495% CI: [-1.95, 6.02]Cochran-Mantel-Haenszel
Comparison: 15 minutes95% CI: [0, 0]Cochran-Mantel-Haenszel
Comparison: 15 minutesp-value: 0.46995% CI: [-1.71, 5.27]Cochran-Mantel-Haenszel
Comparison: 30 minutesp-value: 0.10195% CI: [1.33, 16.93]Cochran-Mantel-Haenszel
Comparison: 30 minutesp-value: 0.06995% CI: [2.54, 18.91]Cochran-Mantel-Haenszel
Comparison: 30 minutesp-value: 0.30395% CI: [-1.39, 8.57]Cochran-Mantel-Haenszel
Comparison: 45 minutesp-value: 0.00895% CI: [10.68, 38.47]Cochran-Mantel-Haenszel
Comparison: 45 minutesp-value: 0.00795% CI: [11.35, 39.28]Cochran-Mantel-Haenszel
Comparison: 45 minutesp-value: 0.12995% CI: [-0.68, 21.92]Cochran-Mantel-Haenszel
Comparison: 60 minutesp-value: <0.00195% CI: [32.25, 63.19]Cochran-Mantel-Haenszel
Comparison: 60 minutesp-value: <0.00195% CI: [21.24, 50.78]Cochran-Mantel-Haenszel
Comparison: 60 minutesp-value: 0.00395% CI: [13.93, 41.81]Cochran-Mantel-Haenszel
Comparison: 90 minutesp-value: <0.00195% CI: [46.12, 75.89]Cochran-Mantel-Haenszel
Comparison: 90 minutesp-value: <0.00195% CI: [38.85, 68.8]Cochran-Mantel-Haenszel
Comparison: 90 minutesp-value: <0.00195% CI: [31.89, 61.58]Cochran-Mantel-Haenszel
Comparison: 120 minutesp-value: <0.00195% CI: [49.37, 80.18]Cochran-Mantel-Haenszel
Comparison: 120 minutesp-value: <0.00195% CI: [50.01, 79.59]Cochran-Mantel-Haenszel
Comparison: 120 minutesp-value: <0.00195% CI: [34.27, 66.11]Cochran-Mantel-Haenszel
Comparison: 180 minutesp-value: <0.00195% CI: [52.81, 84.38]Cochran-Mantel-Haenszel
Comparison: 180 minutesp-value: <0.00195% CI: [57.05, 87.26]Cochran-Mantel-Haenszel
Comparison: 180 minutesp-value: <0.00195% CI: [36.57, 70.37]Cochran-Mantel-Haenszel
Comparison: 240 minutesp-value: <0.00195% CI: [57.48, 87.84]Cochran-Mantel-Haenszel
Comparison: 240 minutesp-value: <0.00195% CI: [65.68, 93.05]Cochran-Mantel-Haenszel
Comparison: 240 minutesp-value: <0.00195% CI: [40.46, 73.6]Cochran-Mantel-Haenszel
Comparison: 300 minutesp-value: <0.00195% CI: [57.48, 87.84]Cochran-Mantel-Haenszel
Comparison: 300 minutesp-value: <0.00195% CI: [67.91, 94.49]Cochran-Mantel-Haenszel
Comparison: 300 minutesp-value: <0.00195% CI: [42.34, 75.35]Cochran-Mantel-Haenszel
Comparison: 360 minutesp-value: <0.00195% CI: [53.33, 85.33]Cochran-Mantel-Haenszel
Comparison: 360 minutesp-value: <0.00195% CI: [63.57, 92.06]Cochran-Mantel-Haenszel
Comparison: 360 minutesp-value: <0.00195% CI: [41.88, 75.84]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Treatment Failure
Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy.
Time frame: 8, 9, 10, 11, and 12 hours
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Treatment Failure | 11 hours | 82.8 percentage of participants |
| Placebo | Percentage of Participants With Treatment Failure | 10 hours | 82.8 percentage of participants |
| Placebo | Percentage of Participants With Treatment Failure | 12 hours | 82.8 percentage of participants |
| Placebo | Percentage of Participants With Treatment Failure | 9 hours | 82.8 percentage of participants |
| Placebo | Percentage of Participants With Treatment Failure | 8 hours | 82.8 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants With Treatment Failure | 8 hours | 11.3 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants With Treatment Failure | 9 hours | 11.3 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants With Treatment Failure | 10 hours | 17.0 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants With Treatment Failure | 11 hours | 20.8 percentage of participants |
| Ibuprofen IR/ER (Roller Compaction) | Percentage of Participants With Treatment Failure | 12 hours | 20.8 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants With Treatment Failure | 11 hours | 14.3 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants With Treatment Failure | 8 hours | 12.5 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants With Treatment Failure | 9 hours | 12.5 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants With Treatment Failure | 12 hours | 17.9 percentage of participants |
| Ibuprofen IR/ER (Wet Granulation) | Percentage of Participants With Treatment Failure | 10 hours | 12.5 percentage of participants |
| Naproxen | Percentage of Participants With Treatment Failure | 8 hours | 24.1 percentage of participants |
| Naproxen | Percentage of Participants With Treatment Failure | 12 hours | 32.8 percentage of participants |
| Naproxen | Percentage of Participants With Treatment Failure | 11 hours | 27.6 percentage of participants |
| Naproxen | Percentage of Participants With Treatment Failure | 10 hours | 27.6 percentage of participants |
| Naproxen | Percentage of Participants With Treatment Failure | 9 hours | 25.9 percentage of participants |
Comparison: 8 hoursp-value: <0.00195% CI: [-88.56, -55.83]Cochran-Mantel-Haenszel
Comparison: 8 hoursp-value: <0.00195% CI: [-87.14, -54.3]Cochran-Mantel-Haenszel
Comparison: 8 hoursp-value: <0.00195% CI: [-76.94, -42.27]Cochran-Mantel-Haenszel
Comparison: 9 hoursp-value: <0.00195% CI: [-88.56, -55.83]Cochran-Mantel-Haenszel
Comparison: 9 hoursp-value: <0.00195% CI: [-87.14, -54.3]Cochran-Mantel-Haenszel
Comparison: 9 hoursp-value: <0.00195% CI: [-75.43, -40.16]Cochran-Mantel-Haenszel
Comparison: 10 hoursp-value: <0.00195% CI: [-83.98, -49.6]Cochran-Mantel-Haenszel
Comparison: 10 hoursp-value: <0.00195% CI: [-87.14, -54.3]Cochran-Mantel-Haenszel
Comparison: 10 hoursp-value: <0.00195% CI: [-73.85, -38.11]Cochran-Mantel-Haenszel
Comparison: 11 hoursp-value: <0.00195% CI: [-80.82, -46.06]Cochran-Mantel-Haenszel
Comparison: 11 hoursp-value: <0.00195% CI: [-85.63, -54.14]Cochran-Mantel-Haenszel
Comparison: 11 hoursp-value: <0.00195% CI: [-73.85, -38.11]Cochran-Mantel-Haenszel
Comparison: 12 hoursp-value: <0.00195% CI: [-80.82, -46.06]Cochran-Mantel-Haenszel
Comparison: 12 hoursp-value: <0.00195% CI: [-82.49, -48.07]Cochran-Mantel-Haenszel
Comparison: 12 hoursp-value: <0.00195% CI: [-69.09, -32.45]Cochran-Mantel-Haenszel
Secondary
Time to First Perceptible Pain Relief
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.
Time frame: Baseline to 6 hours
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Perceptible Pain Relief | NA minutes |
| Ibuprofen IR/ER (Roller Compaction) | Time to First Perceptible Pain Relief | 29.4 minutes |
| Ibuprofen IR/ER (Wet Granulation) | Time to First Perceptible Pain Relief | 29.4 minutes |
| Naproxen | Time to First Perceptible Pain Relief | 32.1 minutes |
Secondary
Time to Meaningful Pain Relief
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.
Time frame: Baseline to 6 hours
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Meaningful Pain Relief | NA minutes |
| Ibuprofen IR/ER (Roller Compaction) | Time to Meaningful Pain Relief | 59.7 minutes |
| Ibuprofen IR/ER (Wet Granulation) | Time to Meaningful Pain Relief | 76.7 minutes |
| Naproxen | Time to Meaningful Pain Relief | 84.1 minutes |
p-value: <0.00195% CI: [4.85, 37.89]Proportional hazards regression
Secondary
Time to Treatment Failure
Time to first rescue medication or discontinuation due to lack of efficacy
Time frame: Baseline to 24 hours
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Treatment Failure | 1.7 hours |
| Ibuprofen IR/ER (Roller Compaction) | Time to Treatment Failure | NA hours |
| Ibuprofen IR/ER (Wet Granulation) | Time to Treatment Failure | NA hours |
| Naproxen | Time to Treatment Failure | NA hours |
Secondary
Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8)
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).
Time frame: 0 to 4 hours and 4 to 8 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Ibuprofen IR/ER (Roller Compaction) | 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 | 8.15 units on a scale | Standard Deviation 4.48 |
| Ibuprofen IR/ER (Roller Compaction) | 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 | 5.44 units on a scale | Standard Deviation 3.21 |
| Ibuprofen IR/ER (Wet Granulation) | 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 | 5.22 units on a scale | Standard Deviation 2.9 |
| Ibuprofen IR/ER (Wet Granulation) | 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 | 8.13 units on a scale | Standard Deviation 4.76 |
| Naproxen | 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 | 3.96 units on a scale | Standard Deviation 2.87 |
| Naproxen | 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 | 5.95 units on a scale | Standard Deviation 4.74 |
Comparison: SPID 0-4p-value: <0.00195% CI: [4.18, 6.51]ANOVA
Comparison: SPID 0-4p-value: <0.00195% CI: [4.09, 6.4]ANOVA
Comparison: SPID 0-4p-value: <0.00195% CI: [2.83, 5.12]ANOVA
Comparison: SPID 4-8p-value: <0.00195% CI: [5.63, 9.43]ANOVA
Comparison: SPID 4-8p-value: <0.00195% CI: [5.8, 9.56]ANOVA
Comparison: SPID 4-8p-value: <0.00195% CI: [3.62, 7.36]ANOVA
Secondary
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID)
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.
Time frame: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 0-12 | 7.09 units on a scale | Standard Deviation 21 |
| Placebo | 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 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 0-12 | 48.76 units on a scale | Standard Deviation 18.99 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 0-4 | 15.48 units on a scale | Standard Deviation 6.6 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 8-12 | 19.36 units on a scale | Standard Deviation 9.94 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 4-8 | 23.21 units on a scale | Standard Deviation 8.85 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 0-12 | 50.01 units on a scale | Standard Deviation 22.32 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 8-12 | 20.73 units on a scale | Standard Deviation 11.43 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 4-8 | 23.14 units on a scale | Standard Deviation 10.12 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 0-4 | 15.12 units on a scale | Standard Deviation 6.1 |
| Naproxen | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 4-8 | 17.71 units on a scale | Standard Deviation 10.69 |
| Naproxen | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 0-4 | 11.97 units on a scale | Standard Deviation 6.51 |
| Naproxen | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 8-12 | 15.86 units on a scale | Standard Deviation 11.56 |
| Naproxen | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | SPRID 0-12 | 38.45 units on a scale | Standard Deviation 22.61 |
Comparison: SPRID 0-4p-value: <0.00195% CI: [10.68, 16.27]ANOVA
Comparison: SPRID 0-4p-value: <0.00195% CI: [10.48, 16.01]ANOVA
Comparison: SPRID 0-4p-value: <0.00195% CI: [7.33, 12.83]ANOVA
Comparison: SPRID 4-8p-value: <0.00195% CI: [14.71, 23.71]ANOVA
Comparison: SPRID 4-8p-value: <0.00195% CI: [14.86, 23.78]ANOVA
Comparison: SPRID 4-8p-value: <0.00195% CI: [9.44, 18.3]ANOVA
Comparison: SPRID 8-12p-value: <0.00195% CI: [11.29, 21.07]ANOVA
Comparison: SPRID 8-12p-value: <0.00195% CI: [12.81, 22.49]ANOVA
Comparison: SPRID 8-12p-value: <0.00195% CI: [7.97, 17.59]ANOVA
Comparison: SPRID 0-12p-value: <0.00195% CI: [31.48, 50.69]ANOVA
Comparison: SPRID 0-12p-value: <0.00195% CI: [33.15, 52.17]ANOVA
Comparison: SPRID 0-12p-value: <0.00195% CI: [21.63, 40.53]ANOVA
Secondary
Time-weighted Sum of Pain Relief Scores (TOTPAR)
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).
Time frame: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-4 | 1.91 units on a scale | Standard Deviation 3.25 |
| Placebo | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 4-8 | 3.38 units on a scale | Standard Deviation 6.43 |
| Placebo | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 8-12 | 3.03 units on a scale | Standard Deviation 5.75 |
| Placebo | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-12 | 7.04 units on a scale | Standard Deviation 12.74 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 4-8 | 15.06 units on a scale | Standard Deviation 4.76 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 8-12 | 12.79 units on a scale | Standard Deviation 5.97 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-12 | 31.89 units on a scale | Standard Deviation 10.67 |
| Ibuprofen IR/ER (Roller Compaction) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-4 | 10.04 units on a scale | Standard Deviation 3.66 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 8-12 | 13.59 units on a scale | Standard Deviation 6.61 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 4-8 | 15.02 units on a scale | Standard Deviation 5.79 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-12 | 32.67 units on a scale | Standard Deviation 12.74 |
| Ibuprofen IR/ER (Wet Granulation) | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-4 | 9.90 units on a scale | Standard Deviation 3.51 |
| Naproxen | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-12 | 25.79 units on a scale | Standard Deviation 13.48 |
| Naproxen | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 4-8 | 11.76 units on a scale | Standard Deviation 6.35 |
| Naproxen | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 0-4 | 8.01 units on a scale | Standard Deviation 3.96 |
| Naproxen | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR 8-12 | 10.72 units on a scale | Standard Deviation 6.89 |
Comparison: TOTPAR 0-4p-value: <0.00195% CI: [6.45, 9.8]ANOVA
Comparison: TOTPAR 0-4p-value: <0.00195% CI: [6.34, 9.65]ANOVA
Comparison: TOTPAR 0-4p-value: <0.00195% CI: [4.46, 7.75]ANOVA
Comparison: TOTPAR 4-8p-value: <0.00195% CI: [9.02, 14.34]ANOVA
Comparison: TOTPAR 4-8p-value: <0.00195% CI: [9.01, 14.27]ANOVA
Comparison: TOTPAR 4-8p-value: <0.00195% CI: [5.76, 11]ANOVA
Comparison: TOTPAR 8-12p-value: <0.00195% CI: [6.93, 12.75]ANOVA
Comparison: TOTPAR 8-12p-value: <0.00195% CI: [7.71, 13.46]ANOVA
Comparison: TOTPAR 8-12p-value: <0.00195% CI: [4.87, 10.59]ANOVA
Comparison: TOTPAR 0-12p-value: <0.00195% CI: [19.24, 30.61]ANOVA
Comparison: TOTPAR 0-12p-value: <0.00195% CI: [20.03, 31.28]ANOVA
Comparison: TOTPAR 0-12p-value: <0.00195% CI: [13.19, 24.38]ANOVA