Efficacy Of Pf-04531083 In Treating Post-Surgical Dental... | NCT01512160

Efficacy Of Pf-04531083 In Treating Post-Surgical Dental... | NCT01512160 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
PF-04531083 2000 mg	Experimental	Drug: PF-04531083 Other: Placebo
PF-04531083 1000 mg	Experimental	Drug: PF-04531083 Other: Placebo
Ibuprofen 400 mg	Active Comparator	Drug: Ibuprofen Other: Placebo
Placebo	Placebo Comparator	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
PF-04531083	Drug	2000 mg oral solution	PF-04531083 2000 mg
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Pain Relief (TOTPAR) Score From 0 to 6 Hours	TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.	0 to 6 hours

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Peak Pain Relief (PPR)	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).	0 to 24 hours
Time-specific Pain Relief (PR) Score

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Austin	Texas	78744	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

Arm/Group Information

ID	Title	Description
FG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).
FG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
FG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
FG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00022 subjects FG00123 subjects FG00222 subjects FG00323 subjects
COMPLETED		FG00020 subjects FG00123 subjects FG00222 subjects FG00322 subjects
NOT COMPLETED		FG0002 subjects FG0010 subjects FG0020 subjects FG0031 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0001 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Total Pain Relief (TOTPAR) Score From 0 to 6 Hours

TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.

Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

units on a scale*hour

0 to 6 hours

ID	Title	Description
OG000	PF-04531083 1000 mg

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA v15.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Pfizer ClinicalTrials.gov Call Center	Pfizer, Inc.	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

Intervention Browse Module

ID	Term
D007052	Ibuprofen

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Group IDs	Group Description	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG003	Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.	Least squares (LS) mean difference	-1.1	Standard Error of the Mean	1.9	2-Sided	90	-4.3	2.2	No	Superiority or Other
OG001 OG003	ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.	LS mean difference	-0.9	Standard Error of the Mean	1.9	2-Sided	90	-4.1	2.3	No	Superiority or Other
OG002 OG003	ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.	LS mean difference	3.5	Standard Error of the Mean	1.9	2-Sided	90	0.3	6.7	No	Superiority or Other

Secondary

Number of Participants With Peak Pain Relief (PPR)

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).

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Posted

Number

participants

0 to 24 hours

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

None

Title	Measurements
	OG0004 OG0013 OG0023 OG003

Secondary

Time-specific Pain Relief (PR) Score

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

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.

Posted

Mean

Standard Deviation

units on a scale

0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

0 hours (n=22, 23, 22, 23)

Title	Measurements
	OG0000.00± 0.00 OG0010.00± 0.00 OG0020.00± 0.00 OG003

Secondary

Time-specific Pain Intensity Difference (PID) Score

Posted

Mean

Standard Deviation

units on a scale

15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

15 minutes (n=22, 23, 22, 23)

Title	Measurements
	OG0000.14± 0.64 OG0010.17± 0.65 OG0020.18± 0.39 OG003

Secondary

Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours

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

Posted

Least Squares Mean

Standard Error

units on a scale*hour

0 to 6, 0 to 24 hours

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

SPID 0-6

Title	Measurements
	OG0000.9± 1.1 OG0011.0± 1.1 OG0024.1± 1.1 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.					LS mean difference	-0.4	Standard Error of the Mean	1.4	2-Sided	90	-2.8	1.9				No	Superiority or Other
OG001 OG003

Secondary

Total Pain Relief (TOTPAR) Score From 0 to 24 Hours

TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.

Posted

Least Squares Mean

Standard Error

units on a scale*hour

0 to 24 hours

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG00021.8± 7.4 OG00120.7± 7.3 OG00230.8± 7.4 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.					LS mean difference	0.2	Standard Error of the Mean	9.5	2-Sided	90	-15.6	16.1				No	Superiority or Other
OG001 OG003

Secondary

Time to Onset of First Perceptible Pain Relief (PR)

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

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Posted

Median

90% Confidence Interval

hours

0 to 24 hours

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.4(0.2 to 0.8) OG0010.3(0.2 to 0.4) OG0020.4(0.3 to 0.5) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.					Hazard Ratio (HR)	0.8			2-Sided	90	0.5	1.5				No	Superiority or Other
OG001 OG003

Secondary

Time to Onset of First Meaningful Pain Relief (PR)

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

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Posted

Median

90% Confidence Interval

hours

0 to 24 hours

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.0(2.5 to 5.6) OG0014.9(2.0 to NA)Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data. OG0023.3(1.0 to 4.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.					Hazard Ratio (HR)	1.0			2-Sided	90	0.5	2.1				No	Superiority or Other
OG001 OG003	HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.

Secondary

Time to First Use of Rescue Medication

Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Posted

Median

90% Confidence Interval

hours

1.5 to 24 hours

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004.8(1.8 to NA)Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data. OG0012.6(1.7 to 10.4) OG00211.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.					Hazard Ratio (HR)	1.0			2-Sided	90	0.6	1.9				No	Superiority or Other
OG001 OG003	HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.

Secondary

Number of Participants With Rescue Medication

Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Posted

Number

participants

0 to 24 hours

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG00014 OG00116 OG00214 OG003

Secondary

Participant Global Evaluation of Study Medication

Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.

Posted

Number

participants

6, 24 hours, prior to RM

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

6 hours: Excellent

Title	Measurements
	OG0000 OG0012 OG0022 OG003

Secondary

Participant Satisfaction Questionnaire

Participant's response to 2 questions about "how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.

FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.

Posted

Number

participants

6, 24 hours, prior to RM

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

6 hours PR: Very Satisfied

Title	Measurements
	OG0002 OG0011 OG0027 OG003

Secondary

Maximum Observed Plasma Concentration (Cmax) of PF-04531083

Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Geometric Mean

Standard Deviation

nanogram per milliliter (ng/mL)

0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0005761± 1905.0 OG0019433± 3527.0

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083

PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Median

Full Range

hours

0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0004.02(1.02 to 6.28) OG0016.00(2.02 to 24.2)

Secondary

Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083

AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.

PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Geometric Mean

Standard Deviation

nanogram*hour per milliliter (ng*hr/mL)

0 (pre-dose), 1, 2, 4, 6 hours post-dose

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123

Title

Denominators

Categories

Title	Measurements
	OG00021920± 7707.8 OG00134640± 16408.0

Secondary

Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083

AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.

PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123

Title

Denominators

Categories

Title	Measurements
	OG00080140± 23571 OG001147100± 49215

Secondary

Maximum Observed Plasma Concentration (Cmax) of Ibuprofen

PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Geometric Mean

Standard Deviation

microgram per milliliter (mcg/mL)

0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

ID	Title	Description
OG000	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022

Title

Denominators

Categories

(R)-Ibuprofen

Title	Measurements
	OG00010.93± 4.6191

(S)-Ibuprofen

Title	Measurements
	OG00012.10± 3.7848

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen

PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Median

Full Range

hours

0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

ID	Title	Description
OG000	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022

Title

Denominators

Categories

(R)-Ibuprofen

Title	Measurements
	OG0004.02(1.00 to 24.1)

(S)-Ibuprofen

Title	Measurements
	OG0004.02(1.02 to 6.23)

Secondary

Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen

AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.

PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Geometric Mean

Standard Deviation

microgram*hour per milliliter (mcg*h/mL)

0 (pre-dose), 1, 2, 4, 6 hours post-dose

ID	Title	Description
OG000	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022

Title

Denominators

Categories

(R)-Ibuprofen

Title	Measurements
	OG00031.39± 12.847

(S)-Ibuprofen

Title	Measurements
	OG00038.72± 13.070

Secondary

Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen

AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.

PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Posted

Geometric Mean

Standard Deviation

mcg*hr/mL

0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

ID	Title	Description
OG000	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022

Title

Denominators

Categories

(R)-Ibuprofen

Title	Measurements
	OG00056.82± 49.272

(S)-Ibuprofen

Title	Measurements
	OG00082.58± 47.992

Secondary

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

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/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.

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

Posted

Number

participants

Baseline up to Day 10-14 (Follow-up)

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

AEs

Title	Measurements
	OG00013 OG00112 OG00211 OG003

Secondary

Number of Participants With Clinically Significant Laboratory Test Abnormality

Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.

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

Posted

Number

participants

Baseline up to Day 10-14 (Follow-up)

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004 OG0016 OG0025 OG003

Secondary

Supine Systolic and Diastolic Blood Pressure (BP)

Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.

Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.

Posted

Mean

Standard Deviation

mmHg

Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Screening: Systolic BP (n=22, 23, 22, 23)

Title	Measurements
	OG000124.3± 9.70 OG001123.2± 9.62 OG002122.4± 10.05 OG003

Secondary

12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)

Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).

Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.

Posted

Mean

Standard Deviation

milliseconds

Screening, Day 1, 2, 10-14 (Follow-up)

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Screening: PR Interval (n=22, 23, 22, 23)

Title	Measurements
	OG000157.1± 27.69 OG001156.0± 20.64 OG002150.7± 23.17 OG003

Secondary

12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)

Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.

Posted

Mean

Standard Deviation

beats per minute

Screening, Day 1, 2, 10-14 (Follow-up)

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Screening (n=22, 23, 22, 23)

Title	Measurements
	OG00062.2± 11.99 OG00157.1± 10.02 OG00256.5± 8.05 OG003

Secondary

Supine Pulse Rate

Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.

Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.

Posted

Mean

Standard Deviation

beats per minute

Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)

ID	Title	Description
OG000	PF-04531083 1000 mg	Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG001	PF-04531083 2000 mg	Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG002	Ibuprofen 400 mg	Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
OG003	Placebo	Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.

Units	Counts
Participants	OG00022 OG00123 OG00222 OG003

Title

Denominators

Categories

Screening (n=22, 23, 22, 23)

Title	Measurements
	OG00060.1± 13.08 OG00156.2± 10.48 OG00255.1± 7.97 OG003

Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)

Title

Measurements

OG000NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG001NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG002NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG003148.0± NAStandard deviation was not estimable since only 1 participant was evaluable.

Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)

Title

Measurements

OG000NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG001NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG002NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG003102.0± NAStandard deviation was not estimable since only 1 participant was evaluable.

Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)

Title

Measurements

OG000NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG001NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG002NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG003360.0± NAStandard deviation was not estimable since only 1 participant was evaluable.

Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)

Title

Measurements

OG000NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG001NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG002NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG003401.0± NAStandard deviation was not estimable since only 1 participant was evaluable.

Day 10-14 (Follow-up) (n=0, 0, 0, 1)

Title

Measurements

OG000NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG001NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG002NA± NAAs planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.
OG00383.0± NAStandard deviation was not estimable since only 1 participant was evaluable.