Trial Outcomes & Findings for Efficacy Of PF-05089771 In Treating Postoperative Dental Pain (NCT NCT01529346)

Last Updated: 2018-06-01

Results Overview

TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

235 participants

Primary outcome timeframe

0 to 6 hours

Results posted on

2018-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	PF-05089771 150 mg Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Ibuprofen Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Overall Study STARTED	55	54	54	36	36
Overall Study COMPLETED	53	53	52	36	36
Overall Study NOT COMPLETED	2	1	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-05089771 150 mg Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Ibuprofen Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Overall Study Lost to Follow-up	2	0	1	0	0
Overall Study Other	0	1	1	0	0

Baseline Characteristics

Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-05089771 150 mg n=55 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=54 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Total n=235 Participants Total of all reporting groups
Age, Continuous	23.9 years STANDARD_DEVIATION 6.1 • n=5 Participants	23.3 years STANDARD_DEVIATION 4.9 • n=7 Participants	24.0 years STANDARD_DEVIATION 4.9 • n=5 Participants	22.7 years STANDARD_DEVIATION 4.7 • n=4 Participants	24.2 years STANDARD_DEVIATION 6.4 • n=21 Participants	23.6 years STANDARD_DEVIATION 5.4 • n=8 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	9 Participants n=4 Participants	13 Participants n=21 Participants	69 Participants n=8 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	36 Participants n=7 Participants	39 Participants n=5 Participants	27 Participants n=4 Participants	23 Participants n=21 Participants	166 Participants n=8 Participants

PRIMARY outcome

Timeframe: 0 to 6 hours

Population: Full Analysis Set (FAS): all randomized participants who received at least (\>=) 1 dose of study treatment and had \>=1 evaluable (more than or equal to \[\>=\] 90 minutes post-dose) PR score. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using Last Observation Carried Forward (LOCF).

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Total Pain Relief From 0 to 6 Hours (TOTPAR[6])	14.43 units on a scale Standard Deviation 1.110	4.37 units on a scale Standard Deviation 1.082	6.94 units on a scale Standard Deviation 0.898	6.21 units on a scale Standard Deviation 0.915	7.00 units on a scale Standard Deviation 0.906

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.

PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Number of Participants With Peak Pain Relief (PPR) None	1 participants	9 participants	13 participants	13 participants	15 participants
Number of Participants With Peak Pain Relief (PPR) A Little	4 participants	10 participants	11 participants	11 participants	6 participants
Number of Participants With Peak Pain Relief (PPR) Some	1 participants	9 participants	10 participants	10 participants	11 participants
Number of Participants With Peak Pain Relief (PPR) A Lot	11 participants	4 participants	4 participants	9 participants	6 participants
Number of Participants With Peak Pain Relief (PPR) Complete	19 participants	4 participants	16 participants	11 participants	15 participants

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours

Population: FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS.

PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Pain Relief (PR) Score 24 Hours	3.15 units on a scale Standard Error 0.17	2.96 units on a scale Standard Error 0.24	3.59 units on a scale Standard Error 0.16	3.20 units on a scale Standard Error 0.18	3.40 units on a scale Standard Error 0.14
Pain Relief (PR) Score 15 Minutes	0.54 units on a scale Standard Error 0.14	0.63 units on a scale Standard Error 0.14	0.55 units on a scale Standard Error 0.11	0.72 units on a scale Standard Error 0.11	0.65 units on a scale Standard Error 0.11
Pain Relief (PR) Score 30 Minutes	1.36 units on a scale Standard Error 0.18	0.70 units on a scale Standard Error 0.18	0.77 units on a scale Standard Error 0.15	1.09 units on a scale Standard Error 0.14	0.86 units on a scale Standard Error 0.15
Pain Relief (PR) Score 45 Minutes	1.89 units on a scale Standard Error 0.18	0.87 units on a scale Standard Error 0.18	0.90 units on a scale Standard Error 0.15	1.26 units on a scale Standard Error 0.15	0.98 units on a scale Standard Error 0.15
Pain Relief (PR) Score 60 Minutes	2.09 units on a scale Standard Error 0.19	0.79 units on a scale Standard Error 0.19	0.99 units on a scale Standard Error 0.16	1.13 units on a scale Standard Error 0.16	1.10 units on a scale Standard Error 0.16
Pain Relief (PR) Score 90 Minutes	2.42 units on a scale Standard Error 0.20	0.73 units on a scale Standard Error 0.20	1.12 units on a scale Standard Error 0.16	1.06 units on a scale Standard Error 0.16	1.11 units on a scale Standard Error 0.16
Pain Relief (PR) Score 2 Hours	2.48 units on a scale Standard Error 0.22	0.70 units on a scale Standard Error 0.23	1.19 units on a scale Standard Error 0.19	1.23 units on a scale Standard Error 0.19	1.14 units on a scale Standard Error 0.19
Pain Relief (PR) Score 3 Hours	2.85 units on a scale Standard Error 0.20	0.98 units on a scale Standard Error 0.26	1.57 units on a scale Standard Error 0.18	1.63 units on a scale Standard Error 0.19	1.61 units on a scale Standard Error 0.18
Pain Relief (PR) Score 4 Hours	3.07 units on a scale Standard Error 0.19	1.46 units on a scale Standard Error 0.28	1.95 units on a scale Standard Error 0.18	1.79 units on a scale Standard Error 0.20	1.89 units on a scale Standard Error 0.18
Pain Relief (PR) Score 6 Hours	2.97 units on a scale Standard Error 0.21	2.07 units on a scale Standard Error 0.36	2.02 units on a scale Standard Error 0.21	1.92 units on a scale Standard Error 0.24	2.18 units on a scale Standard Error 0.21
Pain Relief (PR) Score 8 Hours	2.65 units on a scale Standard Error 0.22	2.38 units on a scale Standard Error 0.39	2.21 units on a scale Standard Error 0.24	2.20 units on a scale Standard Error 0.28	2.08 units on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours

PID was calculated as pain intensity at baseline (baseline pain severity score range 2 \[moderate\] to 3 \[severe\]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 \[none\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best).

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Pain Intensity Difference (PID) 15 Minutes	0.16 units on a scale Standard Error 0.08	0.14 units on a scale Standard Error 0.08	0.12 units on a scale Standard Error 0.06	0.34 units on a scale Standard Error 0.06	0.21 units on a scale Standard Error 0.07
Pain Intensity Difference (PID) 30 Minutes	0.72 units on a scale Standard Error 0.12	0.13 units on a scale Standard Error 0.12	0.32 units on a scale Standard Error 0.10	0.57 units on a scale Standard Error 0.10	0.42 units on a scale Standard Error 0.10
Pain Intensity Difference (PID) 45 Minutes	0.93 units on a scale Standard Error 0.13	0.22 units on a scale Standard Error 0.13	0.34 units on a scale Standard Error 0.11	0.62 units on a scale Standard Error 0.11	0.44 units on a scale Standard Error 0.11
Pain Intensity Difference (PID) 60 Minutes	1.01 units on a scale Standard Error 0.14	0.28 units on a scale Standard Error 0.14	0.38 units on a scale Standard Error 0.11	0.47 units on a scale Standard Error 0.11	0.41 units on a scale Standard Error 0.11
Pain Intensity Difference (PID) 90 Minutes	1.32 units on a scale Standard Error 0.15	0.06 units on a scale Standard Error 0.15	0.38 units on a scale Standard Error 0.12	0.36 units on a scale Standard Error 0.12	0.45 units on a scale Standard Error 0.12
Pain Intensity Difference (PID) 2 Hours	1.35 units on a scale Standard Error 0.16	0.05 units on a scale Standard Error 0.17	0.45 units on a scale Standard Error 0.14	0.38 units on a scale Standard Error 0.14	0.46 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) 3 Hours	1.56 units on a scale Standard Error 0.14	0.18 units on a scale Standard Error 0.20	0.74 units on a scale Standard Error 0.13	0.76 units on a scale Standard Error 0.14	0.82 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) 4 Hours	1.69 units on a scale Standard Error 0.14	0.52 units on a scale Standard Error 0.22	1.02 units on a scale Standard Error 0.14	0.92 units on a scale Standard Error 0.15	1.03 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) 6 Hours	1.65 units on a scale Standard Error 0.14	0.82 units on a scale Standard Error 0.26	1.05 units on a scale Standard Error 0.15	0.96 units on a scale Standard Error 0.17	1.09 units on a scale Standard Error 0.15
Pain Intensity Difference (PID) 8 Hours	1.40 units on a scale Standard Error 0.16	0.76 units on a scale Standard Error 0.29	1.08 units on a scale Standard Error 0.18	1.11 units on a scale Standard Error 0.21	1.01 units on a scale Standard Error 0.17
Pain Intensity Difference (PID) 24 Hours	1.76 units on a scale Standard Error 0.13	1.70 units on a scale Standard Error 0.19	2.15 units on a scale Standard Error 0.12	1.73 units on a scale Standard Error 0.15	2.00 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: 0 to 6 hours; 0 to 24 hours

SPID: area under the PID effect curve from 0 to 6 hours (SPID\[6\]) and 0 to 24 hours (SPID\[24\]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe).

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Summed Pain Intensity Difference (SPID) SIPD(6)	7.44 units on a scale Standard Error 0.77	0.45 units on a scale Standard Error 0.77	2.52 units on a scale Standard Error 0.63	2.14 units on a scale Standard Error 0.63	2.79 units on a scale Standard Error 0.64
Summed Pain Intensity Difference (SPID) SIPD(24)	24.65 units on a scale Standard Error 3.68	2.26 units on a scale Standard Error 3.67	12.06 units on a scale Standard Error 3.01	5.80 units on a scale Standard Error 3.00	13.08 units on a scale Standard Error 3.03

SECONDARY outcome

Timeframe: 0 to 24 hours

TOTPAR(24) was defined as the total area under the PR curve through the first 24 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Total Pain Relief From 0 to 24 Hours (TOTPAR[24])	51.18 units on a scale Standard Error 5.17	18.63 units on a scale Standard Error 5.16	30.89 units on a scale Standard Error 4.23	22.81 units on a scale Standard Error 4.22	31.19 units on a scale Standard Error 4.26

SECONDARY outcome

Timeframe: 0 to 24 hours

Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief.

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Time to Onset of First Perceptible Pain Relief	0.5 hours Interval 0.3 to 0.6	0.7 hours Interval 0.3 to 1.0	0.6 hours Interval 0.3 to 0.8	0.3 hours Interval 0.3 to 0.5	0.4 hours Interval 0.3 to 0.7

SECONDARY outcome

Timeframe: 0 to 24 hours

Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief.

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Time to Onset of Meaningful Pain Relief	1.3 hours Interval 0.8 to 1.8	4.6 hours Interval 2.9 to The upper limit of 90% CI was not calculable because of censored data.	3.3 hours Interval 2.5 to 4.0	2.7 hours Interval 2.1 to 3.2	3.7 hours Interval 2.6 to 4.7

SECONDARY outcome

Timeframe: 0 to 24 hours

Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Time to First Use of Rescue Medication	12.1 hours Interval 8.9 to The upper limit of 90% CI was not calculable because of censored data.	2.3 hours Interval 1.8 to 2.6	4.0 hours Interval 2.4 to 6.6	2.5 hours Interval 2.3 to 3.7	5.5 hours Interval 2.5 to 10.1

SECONDARY outcome

Timeframe: 6, 24 hours, prior to rescue medication (assessed up to 24 hours)

Population: FAS: all randomized participants who received \>=1 dose of study treatment, had \>=1 evaluable (\>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure.

Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication\[RM\]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent.

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Number of Participants With Global Evaluation of Study Medication Hour 6: Poor	2 participants	0 participants	2 participants	0 participants	3 participants
Number of Participants With Global Evaluation of Study Medication Hour 6: Fair	1 participants	2 participants	6 participants	3 participants	3 participants
Number of Participants With Global Evaluation of Study Medication Hour 6: Good	1 participants	5 participants	11 participants	9 participants	5 participants
Number of Participants With Global Evaluation of Study Medication Hour 6: Very Good	18 participants	1 participants	4 participants	6 participants	11 participants
Number of Participants With Global Evaluation of Study Medication Hour 6: Excellent	7 participants	0 participants	2 participants	2 participants	3 participants
Number of Participants With Global Evaluation of Study Medication Hour 24: Poor	0 participants	0 participants	0 participants	0 participants	2 participants
Number of Participants With Global Evaluation of Study Medication Hour 24: Fair	0 participants	0 participants	2 participants	1 participants	2 participants
Number of Participants With Global Evaluation of Study Medication Hour 24: Good	1 participants	4 participants	7 participants	5 participants	2 participants
Number of Participants With Global Evaluation of Study Medication Hour 24: Very Good	7 participants	3 participants	5 participants	5 participants	5 participants
Number of Participants With Global Evaluation of Study Medication Hour 24: Excellent	6 participants	0 participants	3 participants	1 participants	9 participants
Number of Participants With Global Evaluation of Study Medication Prior to RM: Poor	6 participants	22 participants	26 participants	26 participants	21 participants
Number of Participants With Global Evaluation of Study Medication Prior to RM: Fair	1 participants	6 participants	7 participants	7 participants	9 participants
Number of Participants With Global Evaluation of Study Medication Prior to RM: Good	3 participants	1 participants	4 participants	5 participants	3 participants
Number of Participants With Global Evaluation of Study Medication Prior to RM: Very Good	6 participants	0 participants	0 participants	3 participants	1 participants
Number of Participants With Global Evaluation of Study Medication Prior to RM: Excellent	6 participants	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 6, 24 hours, prior to rescue medication (assessed up to 24 hours)

Participants provided assessment regarding satisfaction with study medication (SM) for pain relief (PR) and overall performance (OP) on a 5-point categorical scale, 1=very dissatisfied (VD), 2=somewhat dissatisfied (SD), 3=neither satisfied nor dissatisfied (NSND), 4=somewhat satisfied (SS) and 5=very satisfied (VS).

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=54 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=53 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Number of Participants With Study Medication Satisfaction SM PR, Hour 6: VS	18 participants	0 participants	5 participants	5 participants	12 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 6: SS	9 participants	6 participants	9 participants	11 participants	7 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 6: NSND	0 participants	0 participants	4 participants	1 participants	1 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 6: SD	2 participants	2 participants	5 participants	3 participants	3 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 6: VD	0 participants	0 participants	2 participants	0 participants	2 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 24: VS	10 participants	0 participants	7 participants	4 participants	13 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 24: SS	3 participants	6 participants	4 participants	6 participants	3 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 24: NSND	0 participants	1 participants	4 participants	2 participants	0 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 24: SD	0 participants	0 participants	2 participants	0 participants	2 participants
Number of Participants With Study Medication Satisfaction SM PR, Hour 24: VD	1 participants	0 participants	0 participants	0 participants	2 participants
Number of Participants With Study Medication Satisfaction SM PR, Prior to RM: VS	9 participants	0 participants	0 participants	3 participants	1 participants
Number of Participants With Study Medication Satisfaction SM PR, Prior to RM: SS	3 participants	0 participants	5 participants	5 participants	1 participants
Number of Participants With Study Medication Satisfaction SM PR, Prior to RM: NSND	3 participants	3 participants	3 participants	4 participants	3 participants
Number of Participants With Study Medication Satisfaction SM PR, Prior to RM: SD	4 participants	9 participants	7 participants	7 participants	9 participants
Number of Participants With Study Medication Satisfaction SM PR, Prior to RM: VD	3 participants	17 participants	21 participants	23 participants	20 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 6: VS	17 participants	0 participants	5 participants	6 participants	12 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 6: SS	9 participants	6 participants	11 participants	9 participants	7 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 6: NSND	1 participants	1 participants	4 participants	4 participants	2 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 6: SD	2 participants	1 participants	3 participants	1 participants	2 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 6: VD	0 participants	0 participants	2 participants	0 participants	2 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 24: VS	7 participants	1 participants	7 participants	5 participants	13 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 24: SS	6 participants	5 participants	6 participants	4 participants	3 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 24: NSND	0 participants	1 participants	3 participants	3 participants	1 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 24: SD	0 participants	0 participants	1 participants	0 participants	1 participants
Number of Participants With Study Medication Satisfaction SM OP, Hour 24: VD	1 participants	0 participants	0 participants	0 participants	2 participants
Number of Participants With Study Medication Satisfaction SM OP, Prior to RM: VS	8 participants	0 participants	0 participants	4 participants	1 participants
Number of Participants With Study Medication Satisfaction SM OP, Prior to RM: SS	5 participants	0 participants	4 participants	3 participants	3 participants
Number of Participants With Study Medication Satisfaction SM OP, Prior to RM: NSND	2 participants	4 participants	9 participants	5 participants	3 participants
Number of Participants With Study Medication Satisfaction SM OP, Prior to RM: SD	3 participants	8 participants	7 participants	8 participants	7 participants
Number of Participants With Study Medication Satisfaction SM OP, Prior to RM: VD	4 participants	17 participants	16 participants	22 participants	20 participants

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose

Population: Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period.

Outcome measures

Outcome measures
Measure	Ibuprofen Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=55 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=54 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Plasma PF-05089771 Concentration 0 hour	—	—	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data was not reported since none of the participants had plasma concentration values above lower limit of quantification (LLOQ).	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data was not reported since none of the participants had plasma concentration values above lower limit of quantification (LLOQ).	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data was not reported since none of the participants had plasma concentration values above lower limit of quantification (LLOQ).
Plasma PF-05089771 Concentration 0.5 hour	—	—	1383 nanogram per milliliter (ng/mL) Standard Deviation 1148.6	3497 nanogram per milliliter (ng/mL) Standard Deviation 3111.2	6718 nanogram per milliliter (ng/mL) Standard Deviation 5774.4
Plasma PF-05089771 Concentration 1 hour	—	—	3283 nanogram per milliliter (ng/mL) Standard Deviation 2614.7	7770 nanogram per milliliter (ng/mL) Standard Deviation 5928.5	17890 nanogram per milliliter (ng/mL) Standard Deviation 13217
Plasma PF-05089771 Concentration 2 hours	—	—	5647 nanogram per milliliter (ng/mL) Standard Deviation 4144.6	14470 nanogram per milliliter (ng/mL) Standard Deviation 10612	31260 nanogram per milliliter (ng/mL) Standard Deviation 17354
Plasma PF-05089771 Concentration 4 hours	—	—	4831 nanogram per milliliter (ng/mL) Standard Deviation 2436.8	14110 nanogram per milliliter (ng/mL) Standard Deviation 7966.7	33760 nanogram per milliliter (ng/mL) Standard Deviation 18706
Plasma PF-05089771 Concentration 6 hours	—	—	3826 nanogram per milliliter (ng/mL) Standard Deviation 2261.7	11410 nanogram per milliliter (ng/mL) Standard Deviation 6389.5	31390 nanogram per milliliter (ng/mL) Standard Deviation 16894
Plasma PF-05089771 Concentration 8 hours	—	—	2874 nanogram per milliliter (ng/mL) Standard Deviation 1574.3	9818 nanogram per milliliter (ng/mL) Standard Deviation 5280.2	29830 nanogram per milliliter (ng/mL) Standard Deviation 16355
Plasma PF-05089771 Concentration 10 hours	—	—	2007 nanogram per milliliter (ng/mL) Standard Deviation 1195.5	7916 nanogram per milliliter (ng/mL) Standard Deviation 4018.3	24010 nanogram per milliliter (ng/mL) Standard Deviation 13993
Plasma PF-05089771 Concentration 24 hours	—	—	498.0 nanogram per milliliter (ng/mL) Standard Deviation 344.82	2115 nanogram per milliliter (ng/mL) Standard Deviation 1394.6	8521 nanogram per milliliter (ng/mL) Standard Deviation 5388.1

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose

Population: Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period.

Ibuprofen concentration was reported separately for 2 isomers of ibuprofen: (S)-Ibuprofen, and (R)-Ibuprofen, where S implied sinister (clockwise configuration) and R implied rectus (anti-clockwise configuration).

Outcome measures

Outcome measures
Measure	Ibuprofen Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=36 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Plasma Ibuprofen Concentration (R)-Ibuprofen 0 hour	—	—	0.0054 microgram per milliliter (mcg/mL) Standard Deviation 0.0325	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 0.5 hour	—	—	5.510 microgram per milliliter (mcg/mL) Standard Deviation 6.3603	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 1 hour	—	—	7.049 microgram per milliliter (mcg/mL) Standard Deviation 6.8608	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 2 hours	—	—	9.042 microgram per milliliter (mcg/mL) Standard Deviation 6.3054	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 4 hours	—	—	6.522 microgram per milliliter (mcg/mL) Standard Deviation 4.7188	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 6 hours	—	—	2.574 microgram per milliliter (mcg/mL) Standard Deviation 2.3774	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 8 hours	—	—	1.081 microgram per milliliter (mcg/mL) Standard Deviation 1.4523	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 10 hours	—	—	0.4424 microgram per milliliter (mcg/mL) Standard Deviation 0.5976	—	—
Plasma Ibuprofen Concentration (R)-Ibuprofen 24 hours	—	—	0.0768 microgram per milliliter (mcg/mL) Standard Deviation 0.4028	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 0 hour	—	—	NA microgram per milliliter (mcg/mL) Standard Deviation NA Data was not reported since none of the participants had plasma concentration values above lower limit of quantification (LLOQ).	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 0.5 hour	—	—	4.343 microgram per milliliter (mcg/mL) Standard Deviation 5.0224	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 1 hour	—	—	5.623 microgram per milliliter (mcg/mL) Standard Deviation 5.4780	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 2 hours	—	—	7.356 microgram per milliliter (mcg/mL) Standard Deviation 4.9376	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 4 hours	—	—	9.638 microgram per milliliter (mcg/mL) Standard Deviation 4.1646	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 6 hours	—	—	6.039 microgram per milliliter (mcg/mL) Standard Deviation 3.1734	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 8 hours	—	—	3.597 microgram per milliliter (mcg/mL) Standard Deviation 2.4122	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 10 hours	—	—	1.955 microgram per milliliter (mcg/mL) Standard Deviation 1.6135	—	—
Plasma Ibuprofen Concentration (S)-Ibuprofen 24 hours	—	—	0.1041 microgram per milliliter (mcg/mL) Standard Deviation 0.4332	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 28 (follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 28 days that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=55 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=54 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Adverse Events	12 participants	16 participants	22 participants	24 participants	28 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Serious Adverse Events	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Day 7 to 10 (follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes), blood chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, blood urea nitrogen, fasting glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase), and urinalysis (urine white blood cells, urine red blood cells) were performed.

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=55 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=54 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Number of Participants With Clinically Significant Laboratory Findings	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Day 7 to 10 (follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Clinically significant vital signs: supine/sitting pulse rate (PR) less than (\<) 40 or more than (\>) 120 beats per minute (bpm), standing PR \<40 or \>140 bpm; systolic blood pressure (BP) \>=30 millimeters of mercury (mmHg) change from baseline; absolute systolic BP \<90 mmHg; diastolic BP \>=20 mmHg change from baseline; absolute systolic BP \<50 mmHg.

Outcome measures

Outcome measures
Measure	Ibuprofen n=36 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	Placebo n=36 Participants Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 150 mg n=55 Participants Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter \[mm\] on a 100 mm Visual Analog Scale \[VAS\] pain severity rating scale).	PF-05089771 450 mg n=54 Participants Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).	PF-05089771 1600 mg n=54 Participants Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale).
Number of Participants With Clinically Significant Vital Signs	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Day 7 to 10 (follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Clinically significant ECG abnormalities: PR interval \>=300 milliseconds (msec); 25% increase from baseline in PR interval when baseline PR was \>200 msec; an increase from baseline of \>=50% in PR interval when baseline PR was \<=200 msec; QRS interval \>=140 msec; an increase from baseline of \>=50% in QRS interval; corrected QT interval (QTc) \>=500 msec.