Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01512160

Enrollment

Registered

2012-01-19

Start date

2011-10-31

Completion date

2012-05-31

Last updated

2013-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-surgical Dental Pain

Keywords

Post-surgical dental pain

Brief summary

The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.

Interventions

DRUGPF-04531083

2000 mg oral solution

OTHERPlacebo

Placebo tablets for Ibuprofen

DRUGIbuprofen

2 x 200 mg tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Oral surgical procedure having removed 2 third molars (unilateral). * Pre-dose pain intensity score (100 mm Visual Analog Scale \[VAS\]) \>50 mm within 5 hours of oral surgery. * Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.

Exclusion criteria

* Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder. * Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure. * Recent history of chronic analgesic or tranquilizer dependency. * Active dental infection at the time of surgery. * Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting \> 30 minutes. * Subjects who are smokers.

Design outcomes

Primary

Measure	Time frame	Description
Total Pain Relief (TOTPAR) Score From 0 to 6 Hours	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.

Secondary

Measure	Time frame	Description
Time-specific Pain Relief (PR) Score	0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)	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.
Time-specific Pain Intensity Difference (PID) Score	15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM	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.
Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	0 to 6, 0 to 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.
Total Pain Relief (TOTPAR) Score From 0 to 24 Hours	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.
Time to Onset of First Perceptible Pain Relief (PR)	0 to 24 hours	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.
Time to Onset of First Meaningful Pain Relief (PR)	0 to 24 hours	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.
Time to First Use of Rescue Medication	1.5 to 24 hours	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.
Number of Participants With Rescue Medication	0 to 24 hours	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.
Participant Global Evaluation of Study Medication	6, 24 hours, prior to RM	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.
Participant Satisfaction Questionnaire	6, 24 hours, prior to RM	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.
Maximum Observed Plasma Concentration (Cmax) of PF-04531083	0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083	0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose	—
Number of Participants With Peak Pain Relief (PPR)	0 to 24 hours	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).
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083	0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose	AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.
Maximum Observed Plasma Concentration (Cmax) of Ibuprofen	0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen	0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose	—
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen	0 (pre-dose), 1, 2, 4, 6 hours post-dose	AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen	0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose	AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	Baseline up to Day 10-14 (Follow-up)	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.
Number of Participants With Clinically Significant Laboratory Test Abnormality	Baseline up to Day 10-14 (Follow-up)	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.
Supine Systolic and Diastolic Blood Pressure (BP)	Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)	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.
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening, Day 1, 2, 10-14 (Follow-up)	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).
12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Screening, Day 1, 2, 10-14 (Follow-up)	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.
Supine Pulse Rate	Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)	Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083	0 (pre-dose), 1, 2, 4, 6 hours post-dose	AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	22
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.	23
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.	22
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.	23
Total	90

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	1	0	0	0
Overall Study	Withdrawal by Subject	1	0	0	1

Baseline characteristics

Characteristic	PF-04531083 1000 mg	PF-04531083 2000 mg	Ibuprofen 400 mg	Placebo	Total
Age Continuous	22.9 years STANDARD_DEVIATION 3.7	23.4 years STANDARD_DEVIATION 5.7	25.3 years STANDARD_DEVIATION 4.5	25.3 years STANDARD_DEVIATION 5.4	24.2 years STANDARD_DEVIATION 4.9
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	22 Participants	23 Participants	22 Participants	23 Participants	90 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	13 / 22	10 / 23	8 / 22	5 / 23
serious Total, serious adverse events	0 / 22	0 / 23	0 / 22	0 / 23

Outcome results

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.

Time frame: 0 to 6 hours

Population: 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).

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04531083 1000 mg	Total Pain Relief (TOTPAR) Score From 0 to 6 Hours	4.3 units on a scale*hour	Standard Error 1.5
PF-04531083 2000 mg	Total Pain Relief (TOTPAR) Score From 0 to 6 Hours	4.4 units on a scale*hour	Standard Error 1.5
Ibuprofen 400 mg	Total Pain Relief (TOTPAR) Score From 0 to 6 Hours	8.8 units on a scale*hour	Standard Error 1.5
Placebo	Total Pain Relief (TOTPAR) Score From 0 to 6 Hours	5.3 units on a scale*hour	Standard Error 1.5

Comparison: 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.90% CI: [-4.3, 2.2]

Comparison: 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.90% CI: [-4.1, 2.3]

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.

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Screening (n=22, 23, 22, 23)	62.2 beats per minute	Standard Deviation 11.99
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 1 (n=22, 23, 22, 23)	69.1 beats per minute	Standard Deviation 10.3
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 2 (n=22, 23, 22, 23)	67.2 beats per minute	Standard Deviation 9.83
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 10-14 (Follow-up) (n=0, 0, 0, 1)	NA beats per minute	—
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 1 (n=22, 23, 22, 23)	61.7 beats per minute	Standard Deviation 7.08
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 10-14 (Follow-up) (n=0, 0, 0, 1)	NA beats per minute	—
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Screening (n=22, 23, 22, 23)	57.1 beats per minute	Standard Deviation 10.02
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 2 (n=22, 23, 22, 23)	62.5 beats per minute	Standard Deviation 11.6
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Screening (n=22, 23, 22, 23)	56.5 beats per minute	Standard Deviation 8.05
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 10-14 (Follow-up) (n=0, 0, 0, 1)	NA beats per minute	—
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 2 (n=22, 23, 22, 23)	66.3 beats per minute	Standard Deviation 10.09
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 1 (n=22, 23, 22, 23)	64.0 beats per minute	Standard Deviation 9.51
Placebo	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 10-14 (Follow-up) (n=0, 0, 0, 1)	83.0 beats per minute	—
Placebo	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Screening (n=22, 23, 22, 23)	58.0 beats per minute	Standard Deviation 8.54
Placebo	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 1 (n=22, 23, 22, 23)	65.8 beats per minute	Standard Deviation 10.89
Placebo	12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)	Day 2 (n=22, 23, 22, 23)	64.3 beats per minute	Standard Deviation 8.26

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).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: PR Interval (n=22, 23, 22, 23)	157.1 milliseconds	Standard Deviation 27.69
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: PR Interval (n=22, 23, 22, 23)	154.2 milliseconds	Standard Deviation 21.51
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QT Interval (n=22, 23, 22, 23)	372.0 milliseconds	Standard Deviation 18.27
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QRS Interval (n=22, 23, 22, 23)	90.3 milliseconds	Standard Deviation 8.33
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QRS Interval (n=22, 23, 22, 23)	89.7 milliseconds	Standard Deviation 7.15
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QT Interval (n=22, 23, 22, 23)	381.1 milliseconds	Standard Deviation 24.91
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QRS Interval (n=22, 23, 22, 23)	87.6 milliseconds	Standard Deviation 7.63
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QTcF Interval (n=22, 23, 22, 23)	394.0 milliseconds	Standard Deviation 14.76
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QT Interval (n=22, 23, 22, 23)	398.4 milliseconds	Standard Deviation 34.27
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QTcF Interval (n=22, 23, 22, 23)	399.8 milliseconds	Standard Deviation 16.34
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: PR Interval (n=22, 23, 22, 23)	156.9 milliseconds	Standard Deviation 22.83
PF-04531083 1000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QTcF Interval (n=22, 23, 22, 23)	388.5 milliseconds	Standard Deviation 15.48
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QTcF Interval (n=22, 23, 22, 23)	403.6 milliseconds	Standard Deviation 18.33
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)	NA milliseconds	—
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: PR Interval (n=22, 23, 22, 23)	148.7 milliseconds	Standard Deviation 18.71
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QRS Interval (n=22, 23, 22, 23)	95.0 milliseconds	Standard Deviation 9.96
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QRS Interval (n=22, 23, 22, 23)	95.8 milliseconds	Standard Deviation 9.96
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QT Interval (n=22, 23, 22, 23)	391.1 milliseconds	Standard Deviation 27.39
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QTcF Interval (n=22, 23, 22, 23)	393.4 milliseconds	Standard Deviation 18.82
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: PR Interval (n=22, 23, 22, 23)	156.0 milliseconds	Standard Deviation 20.64
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: PR Interval (n=22, 23, 22, 23)	149.1 milliseconds	Standard Deviation 17.79
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QRS Interval (n=22, 23, 22, 23)	93.7 milliseconds	Standard Deviation 8.1
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QT Interval (n=22, 23, 22, 23)	413.2 milliseconds	Standard Deviation 34.29
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QT Interval (n=22, 23, 22, 23)	395.5 milliseconds	Standard Deviation 32.99
PF-04531083 2000 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QTcF Interval (n=22, 23, 22, 23)	397.9 milliseconds	Standard Deviation 18.87
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QTcF Interval (n=22, 23, 22, 23)	396.6 milliseconds	Standard Deviation 19.03
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)	NA milliseconds	—
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QT Interval (n=22, 23, 22, 23)	385.8 milliseconds	Standard Deviation 32.91
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: PR Interval (n=22, 23, 22, 23)	150.8 milliseconds	Standard Deviation 22.86
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)	NA milliseconds	—
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)	NA milliseconds	—
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QT Interval (n=22, 23, 22, 23)	410.7 milliseconds	Standard Deviation 25.43
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QRS Interval (n=22, 23, 22, 23)	91.5 milliseconds	Standard Deviation 7.9
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QRS Interval (n=22, 23, 22, 23)	88.5 milliseconds	Standard Deviation 11.73
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: PR Interval (n=22, 23, 22, 23)	148.4 milliseconds	Standard Deviation 23.81
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)	NA milliseconds	—
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QT Interval (n=22, 23, 22, 23)	388.7 milliseconds	Standard Deviation 28.41
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QRS Interval (n=22, 23, 22, 23)	93.2 milliseconds	Standard Deviation 8.74
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QTcF Interval (n=22, 23, 22, 23)	400.9 milliseconds	Standard Deviation 16.33
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: PR Interval (n=22, 23, 22, 23)	150.7 milliseconds	Standard Deviation 23.17
Ibuprofen 400 mg	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QTcF Interval (n=22, 23, 22, 23)	395.3 milliseconds	Standard Deviation 17.66
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QRS Interval (n=22, 23, 22, 23)	90.4 milliseconds	Standard Deviation 8.38
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: PR Interval (n=22, 23, 22, 23)	156.4 milliseconds	Standard Deviation 22.12
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QRS Interval (n=22, 23, 22, 23)	93.7 milliseconds	Standard Deviation 8.68
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QT Interval (n=22, 23, 22, 23)	410.3 milliseconds	Standard Deviation 26.56
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Screening: QTcF Interval (n=22, 23, 22, 23)	404.0 milliseconds	Standard Deviation 17.03
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: PR Interval (n=22, 23, 22, 23)	152.5 milliseconds	Standard Deviation 14.93
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QRS Interval (n=22, 23, 22, 23)	90.8 milliseconds	Standard Deviation 8.96
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QT Interval (n=22, 23, 22, 23)	388.9 milliseconds	Standard Deviation 28
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 1: QTcF Interval (n=22, 23, 22, 23)	398.7 milliseconds	Standard Deviation 15.14
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: PR Interval (n=22, 23, 22, 23)	153.9 milliseconds	Standard Deviation 18.33
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)	360.0 milliseconds	—
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QT Interval (n=22, 23, 22, 23)	396.7 milliseconds	Standard Deviation 26.22
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 2: QTcF Interval (n=22, 23, 22, 23)	404.2 milliseconds	Standard Deviation 16.82
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)	148.0 milliseconds	—
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)	102.0 milliseconds	—
Placebo	12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)	Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)	401.0 milliseconds	—

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.

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
PF-04531083 1000 mg	Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen	(R)-Ibuprofen	56.82 mcg*hr/mL	Standard Deviation 49.272
PF-04531083 1000 mg	Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen	(S)-Ibuprofen	82.58 mcg*hr/mL	Standard Deviation 47.992

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.

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

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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
PF-04531083 1000 mg	Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083	80140 ng*hr/mL	Standard Deviation 23571
PF-04531083 2000 mg	Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083	147100 ng*hr/mL	Standard Deviation 49215

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.

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
PF-04531083 1000 mg	Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen	(R)-Ibuprofen	31.39 microgramhour per milliliter (mcgh/mL)	Standard Deviation 12.847
PF-04531083 1000 mg	Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen	(S)-Ibuprofen	38.72 microgramhour per milliliter (mcgh/mL)	Standard Deviation 13.07

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.

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

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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
PF-04531083 1000 mg	Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083	21920 nanogramhour per milliliter (nghr/mL)	Standard Deviation 7707.8
PF-04531083 2000 mg	Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083	34640 nanogramhour per milliliter (nghr/mL)	Standard Deviation 16408

Secondary

Maximum Observed Plasma Concentration (Cmax) of Ibuprofen

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
PF-04531083 1000 mg	Maximum Observed Plasma Concentration (Cmax) of Ibuprofen	(S)-Ibuprofen	12.10 microgram per milliliter (mcg/mL)	Standard Deviation 3.7848
PF-04531083 1000 mg	Maximum Observed Plasma Concentration (Cmax) of Ibuprofen	(R)-Ibuprofen	10.93 microgram per milliliter (mcg/mL)	Standard Deviation 4.6191

Secondary

Maximum Observed Plasma Concentration (Cmax) of PF-04531083

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

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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
PF-04531083 1000 mg	Maximum Observed Plasma Concentration (Cmax) of PF-04531083	5761 nanogram per milliliter (ng/mL)	Standard Deviation 1905
PF-04531083 2000 mg	Maximum Observed Plasma Concentration (Cmax) of PF-04531083	9433 nanogram per milliliter (ng/mL)	Standard Deviation 3527

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.

Time frame: Baseline up to Day 10-14 (Follow-up)

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

Arm	Measure	Value (NUMBER)
PF-04531083 1000 mg	Number of Participants With Clinically Significant Laboratory Test Abnormality	4 participants
PF-04531083 2000 mg	Number of Participants With Clinically Significant Laboratory Test Abnormality	6 participants
Ibuprofen 400 mg	Number of Participants With Clinically Significant Laboratory Test Abnormality	5 participants
Placebo	Number of Participants With Clinically Significant Laboratory Test Abnormality	6 participants

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).

Time frame: 0 to 24 hours

Arm	Measure	Group	Value (NUMBER)
PF-04531083 1000 mg	Number of Participants With Peak Pain Relief (PPR)	A Lot	5 participants
PF-04531083 1000 mg	Number of Participants With Peak Pain Relief (PPR)	A Little	4 participants
PF-04531083 1000 mg	Number of Participants With Peak Pain Relief (PPR)	Complete	5 participants
PF-04531083 1000 mg	Number of Participants With Peak Pain Relief (PPR)	Some	4 participants
PF-04531083 1000 mg	Number of Participants With Peak Pain Relief (PPR)	None	4 participants
PF-04531083 2000 mg	Number of Participants With Peak Pain Relief (PPR)	Some	7 participants
PF-04531083 2000 mg	Number of Participants With Peak Pain Relief (PPR)	A Lot	0 participants
PF-04531083 2000 mg	Number of Participants With Peak Pain Relief (PPR)	Complete	7 participants
PF-04531083 2000 mg	Number of Participants With Peak Pain Relief (PPR)	A Little	6 participants
PF-04531083 2000 mg	Number of Participants With Peak Pain Relief (PPR)	None	3 participants
Ibuprofen 400 mg	Number of Participants With Peak Pain Relief (PPR)	Some	3 participants
Ibuprofen 400 mg	Number of Participants With Peak Pain Relief (PPR)	None	3 participants
Ibuprofen 400 mg	Number of Participants With Peak Pain Relief (PPR)	A Little	3 participants
Ibuprofen 400 mg	Number of Participants With Peak Pain Relief (PPR)	A Lot	6 participants
Ibuprofen 400 mg	Number of Participants With Peak Pain Relief (PPR)	Complete	7 participants
Placebo	Number of Participants With Peak Pain Relief (PPR)	A Lot	5 participants
Placebo	Number of Participants With Peak Pain Relief (PPR)	A Little	4 participants
Placebo	Number of Participants With Peak Pain Relief (PPR)	None	4 participants
Placebo	Number of Participants With Peak Pain Relief (PPR)	Some	4 participants
Placebo	Number of Participants With Peak Pain Relief (PPR)	Complete	6 participants

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.

Time frame: 0 to 24 hours

Arm	Measure	Value (NUMBER)
PF-04531083 1000 mg	Number of Participants With Rescue Medication	14 participants
PF-04531083 2000 mg	Number of Participants With Rescue Medication	16 participants
Ibuprofen 400 mg	Number of Participants With Rescue Medication	14 participants
Placebo	Number of Participants With Rescue Medication	16 participants

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.

Time frame: Baseline up to Day 10-14 (Follow-up)

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

Arm	Measure	Group	Value (NUMBER)
PF-04531083 1000 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	AEs	13 participants
PF-04531083 1000 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	SAEs	0 participants
PF-04531083 2000 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	SAEs	0 participants
PF-04531083 2000 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	AEs	12 participants
Ibuprofen 400 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	AEs	11 participants
Ibuprofen 400 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	SAEs	0 participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	AEs	9 participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	SAEs	0 participants

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.

Time frame: 6, 24 hours, prior to RM

Population: 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.

Arm	Measure	Group	Value (NUMBER)
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	6 hours: Excellent	0 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Excellent	0 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	24 hours: Not Done	14 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	6 hours: Not Done	11 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	24 hours: Poor	0 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	6 hours: Fair	1 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Good	2 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	24 hours: Excellent	1 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	24 hours: Fair	0 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Poor	8 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	6 hours: Very Good	2 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	24 hours: Very Good	5 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Fair	4 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	6 hours: Poor	1 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Very Good	0 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	24 hours: Good	2 participants
PF-04531083 1000 mg	Participant Global Evaluation of Study Medication	6 hours: Good	7 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	24 hours: Good	2 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	24 hours: Fair	0 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	6 hours: Good	4 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Excellent	0 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	24 hours: Poor	0 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Poor	11 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	24 hours: Not Done	16 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	6 hours: Fair	2 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	6 hours: Poor	0 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	6 hours: Very Good	1 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Good	1 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	6 hours: Not Done	14 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	6 hours: Excellent	2 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	24 hours: Excellent	2 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Very Good	0 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	24 hours: Very Good	3 participants
PF-04531083 2000 mg	Participant Global Evaluation of Study Medication	Prior to RM: Fair	4 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	Prior to RM: Fair	2 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	6 hours: Excellent	2 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	6 hours: Very Good	10 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	6 hours: Good	3 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	6 hours: Fair	0 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	6 hours: Poor	0 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	6 hours: Not Done	7 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	24 hours: Excellent	2 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	24 hours: Very Good	5 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	24 hours: Good	1 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	24 hours: Fair	0 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	24 hours: Poor	0 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	24 hours: Not Done	14 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	Prior to RM: Excellent	1 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	Prior to RM: Very Good	4 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	Prior to RM: Good	2 participants
Ibuprofen 400 mg	Participant Global Evaluation of Study Medication	Prior to RM: Poor	5 participants
Placebo	Participant Global Evaluation of Study Medication	24 hours: Good	3 participants
Placebo	Participant Global Evaluation of Study Medication	Prior to RM: Excellent	0 participants
Placebo	Participant Global Evaluation of Study Medication	24 hours: Very Good	0 participants
Placebo	Participant Global Evaluation of Study Medication	24 hours: Excellent	4 participants
Placebo	Participant Global Evaluation of Study Medication	6 hours: Excellent	1 participants
Placebo	Participant Global Evaluation of Study Medication	Prior to RM: Very Good	2 participants
Placebo	Participant Global Evaluation of Study Medication	6 hours: Not Done	14 participants
Placebo	Participant Global Evaluation of Study Medication	6 hours: Poor	0 participants
Placebo	Participant Global Evaluation of Study Medication	Prior to RM: Poor	9 participants
Placebo	Participant Global Evaluation of Study Medication	Prior to RM: Good	3 participants
Placebo	Participant Global Evaluation of Study Medication	6 hours: Fair	0 participants
Placebo	Participant Global Evaluation of Study Medication	6 hours: Good	3 participants
Placebo	Participant Global Evaluation of Study Medication	Prior to RM: Fair	2 participants
Placebo	Participant Global Evaluation of Study Medication	24 hours: Not Done	16 participants
Placebo	Participant Global Evaluation of Study Medication	24 hours: Poor	0 participants
Placebo	Participant Global Evaluation of Study Medication	24 hours: Fair	0 participants
Placebo	Participant Global Evaluation of Study Medication	6 hours: Very Good	5 participants

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.

Time frame: 6, 24 hours, prior to RM

Arm	Measure	Group	Value (NUMBER)
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Dissatisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours PR: Not Done	14 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours OP: Very Satisfied	3 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Dissatisfied	3 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours PR: Very Dissatisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Satisfied	4 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours OP: Neither Satisfied nor Dissatisfied	1 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Dissatisfied	8 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours OP: Neither Satisfied nor Dissatisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Dissatisfied	8 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Satisfied	6 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours OP: Very Dissatisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours PR: Not Done	11 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours OP: Not Done	14 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Satisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours OP: Very Satisfied	3 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Satisfied	1 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours PR: Very Satisfied	2 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours PR: Neither Satisfied nor Dissatisfied	1 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Dissatisfied	2 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Satisfied	6 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours OP: Very Dissatisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Satisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours OP: Not Done	11 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR:Neither Satisfied nor Dissatisfied	1 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours PR: Very Satisfied	3 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Satisfied	4 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Satisfied	1 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Dissatisfied	2 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours PR: Neither Satisfied nor Dissatisfied	1 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Dissatisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Dissatisfied	4 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	24 hours PR: Very Dissatisfied	0 participants
PF-04531083 1000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP:Neither Satisfied nor Dissatisfied	2 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours PR: Very Satisfied	1 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours OP: Very Satisfied	2 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours PR: Not Done	16 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR:Neither Satisfied nor Dissatisfied	5 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Satisfied	3 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Dissatisfied	2 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Satisfied	3 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Dissatisfied	2 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Satisfied	5 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Dissatisfied	2 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours PR: Very Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours OP: Neither Satisfied nor Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours OP: Very Dissatisfied	1 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours PR: Very Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP:Neither Satisfied nor Dissatisfied	5 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours PR: Neither Satisfied nor Dissatisfied	3 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours PR: Neither Satisfied nor Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours OP: Not Done	14 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours OP: Very Dissatisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Dissatisfied	8 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Satisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Satisfied	1 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours OP: Not Done	16 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Dissatisfied	8 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours PR: Not Done	14 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours OP: Very Satisfied	2 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Satisfied	0 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours OP: Neither Satisfied nor Dissatisfied	2 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	24 hours PR: Very Satisfied	4 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Satisfied	4 participants
PF-04531083 2000 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Satisfied	1 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, PR:Neither Satisfied nor Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours OP: Very Satisfied	5 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Dissatisfied	2 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Dissatisfied	5 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Satisfied	3 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Satisfied	4 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Satisfied	9 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, OP:Neither Satisfied nor Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Satisfied	7 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Dissatisfied	1 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Dissatisfied	6 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours OP: Neither Satisfied nor Dissatisfied	1 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours OP: Very Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours OP: Not Done	7 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours PR: Neither Satisfied nor Dissatisfied	1 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours PR: Very Satisfied	7 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Satisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours PR: Neither Satisfied nor Dissatisfied	1 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Satisfied	2 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours PR: Very Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours PR: Not Done	7 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours PR: Not Done	14 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours PR: Very Satisfied	7 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours OP: Very Satisfied	7 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Satisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours OP: Neither Satisfied nor Dissatisfied	1 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	6 hours PR: Very Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours OP: Very Dissatisfied	0 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	24 hours OP: Not Done	14 participants
Ibuprofen 400 mg	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Satisfied	5 participants
Placebo	Participant Satisfaction Questionnaire	24 hours PR: Very Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	6 hours PR: Not Done	14 participants
Placebo	Participant Satisfaction Questionnaire	6 hours PR: Very Satisfied	4 participants
Placebo	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Satisfied	4 participants
Placebo	Participant Satisfaction Questionnaire	6 hours PR: Neither Satisfied nor Dissatisfied	1 participants
Placebo	Participant Satisfaction Questionnaire	6 hours PR: Somewhat Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	6 hours PR: Very Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	6 hours OP: Very Satisfied	5 participants
Placebo	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Satisfied	3 participants
Placebo	Participant Satisfaction Questionnaire	6 hours OP: Somewhat Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	6 hours OP: Neither Satisfied nor Dissatisfied	1 participants
Placebo	Participant Satisfaction Questionnaire	6 hours OP: Very Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	6 hours OP: Not Done	14 participants
Placebo	Participant Satisfaction Questionnaire	24 hours PR: Very Satisfied	4 participants
Placebo	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Satisfied	3 participants
Placebo	Participant Satisfaction Questionnaire	24 hours PR: Neither Satisfied nor Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	24 hours PR: Somewhat Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	24 hours PR: Not Done	16 participants
Placebo	Participant Satisfaction Questionnaire	24 hours OP: Very Satisfied	4 participants
Placebo	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Satisfied	3 participants
Placebo	Participant Satisfaction Questionnaire	24 hours OP: Neither Satisfied nor Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	24 hours OP: Somewhat Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	24 hours OP: Very Dissatisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	24 hours OP: Not Done	16 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Satisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Satisfied	4 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, PR:Neither Satisfied nor Dissatisfied	2 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, PR: Somewhat Dissatisfied	3 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, PR: Very Dissatisfied	7 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Satisfied	0 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Satisfied	4 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, OP:Neither Satisfied nor Dissatisfied	2 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, OP: Somewhat Dissatisfied	3 participants
Placebo	Participant Satisfaction Questionnaire	Prior to RM, OP: Very Dissatisfied	7 participants

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.

Time frame: 0 to 6, 0 to 24 hours

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04531083 1000 mg	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-6	0.9 units on a scale*hour	Standard Error 1.1
PF-04531083 1000 mg	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-24	4.7 units on a scale*hour	Standard Error 5.4
PF-04531083 2000 mg	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-24	5.6 units on a scale*hour	Standard Error 5.3
PF-04531083 2000 mg	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-6	1.0 units on a scale*hour	Standard Error 1.1
Ibuprofen 400 mg	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-6	4.1 units on a scale*hour	Standard Error 1.1
Ibuprofen 400 mg	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-24	13.3 units on a scale*hour	Standard Error 5.4
Placebo	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-6	1.4 units on a scale*hour	Standard Error 1.1
Placebo	Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours	SPID 0-24	5.7 units on a scale*hour	Standard Error 5.3

Comparison: 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.90% CI: [-2.8, 1.9]

Comparison: SPID 0-24: 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.90% CI: [-12.6, 10.5]

Secondary

Supine Pulse Rate

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

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04531083 1000 mg	Supine Pulse Rate	Day 2 (n=22,23,22,23)	64.1 beats per minute	Standard Deviation 9.59
PF-04531083 1000 mg	Supine Pulse Rate	Day 0 (n=22,23,22,23)	61.6 beats per minute	Standard Deviation 8.56
PF-04531083 1000 mg	Supine Pulse Rate	Day 10-14 (Follow-up) (n=21, 23, 22, 22)	61.3 beats per minute	Standard Deviation 9.91
PF-04531083 1000 mg	Supine Pulse Rate	Day 1 (n=22,23,22,23)	66.4 beats per minute	Standard Deviation 10.06
PF-04531083 1000 mg	Supine Pulse Rate	Screening (n=22, 23, 22, 23)	60.1 beats per minute	Standard Deviation 13.08
PF-04531083 2000 mg	Supine Pulse Rate	Day 1 (n=22,23,22,23)	59.5 beats per minute	Standard Deviation 8.81
PF-04531083 2000 mg	Supine Pulse Rate	Day 2 (n=22,23,22,23)	60.6 beats per minute	Standard Deviation 12.03
PF-04531083 2000 mg	Supine Pulse Rate	Day 10-14 (Follow-up) (n=21, 23, 22, 22)	60.4 beats per minute	Standard Deviation 10.6
PF-04531083 2000 mg	Supine Pulse Rate	Day 0 (n=22,23,22,23)	61.3 beats per minute	Standard Deviation 9.89
PF-04531083 2000 mg	Supine Pulse Rate	Screening (n=22, 23, 22, 23)	56.2 beats per minute	Standard Deviation 10.48
Ibuprofen 400 mg	Supine Pulse Rate	Day 1 (n=22,23,22,23)	61.2 beats per minute	Standard Deviation 7.32
Ibuprofen 400 mg	Supine Pulse Rate	Screening (n=22, 23, 22, 23)	55.1 beats per minute	Standard Deviation 7.97
Ibuprofen 400 mg	Supine Pulse Rate	Day 0 (n=22,23,22,23)	62.1 beats per minute	Standard Deviation 10.23
Ibuprofen 400 mg	Supine Pulse Rate	Day 2 (n=22,23,22,23)	65.9 beats per minute	Standard Deviation 8.71
Ibuprofen 400 mg	Supine Pulse Rate	Day 10-14 (Follow-up) (n=21, 23, 22, 22)	59.6 beats per minute	Standard Deviation 11.81
Placebo	Supine Pulse Rate	Day 2 (n=22,23,22,23)	62.7 beats per minute	Standard Deviation 8.55
Placebo	Supine Pulse Rate	Day 0 (n=22,23,22,23)	63.1 beats per minute	Standard Deviation 12.4
Placebo	Supine Pulse Rate	Screening (n=22, 23, 22, 23)	57.0 beats per minute	Standard Deviation 10.45
Placebo	Supine Pulse Rate	Day 1 (n=22,23,22,23)	59.4 beats per minute	Standard Deviation 9.48
Placebo	Supine Pulse Rate	Day 10-14 (Follow-up) (n=21, 23, 22, 22)	62.0 beats per minute	Standard Deviation 8.91

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.

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Diastolic BP (n=22, 23, 22, 23)	65.9 mmHg	Standard Deviation 9.26
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Diastolic BP (n=22, 23, 22, 23)	71.4 mmHg	Standard Deviation 8.75
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Systolic BP (n=22, 23, 22, 23)	122.8 mmHg	Standard Deviation 12.69
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Diastolic BP (n=22, 23, 22, 23)	71.8 mmHg	Standard Deviation 10.52
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Systolic BP (n=22, 23, 22, 23)	121.2 mmHg	Standard Deviation 10.51
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Systolic BP (n=22, 23, 22, 23)	124.3 mmHg	Standard Deviation 9.7
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Diastolic BP(n=21,23,22,22)	69.7 mmHg	Standard Deviation 11.32
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Systolic BP(n=21,23,22,22 )	122.8 mmHg	Standard Deviation 11.05
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Diastolic BP (n=22, 23, 22, 23)	67.2 mmHg	Standard Deviation 8.89
PF-04531083 1000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Systolic BP (n=22, 23, 22, 23)	128.2 mmHg	Standard Deviation 14.41
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Diastolic BP (n=22, 23, 22, 23)	66.3 mmHg	Standard Deviation 7.07
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Systolic BP (n=22, 23, 22, 23)	123.2 mmHg	Standard Deviation 9.62
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Systolic BP(n=21,23,22,22 )	124.9 mmHg	Standard Deviation 10.7
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Diastolic BP(n=21,23,22,22)	70.6 mmHg	Standard Deviation 9.66
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Systolic BP (n=22, 23, 22, 23)	122.4 mmHg	Standard Deviation 10.14
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Diastolic BP (n=22, 23, 22, 23)	71.1 mmHg	Standard Deviation 6.68
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Systolic BP (n=22, 23, 22, 23)	126.8 mmHg	Standard Deviation 13.17
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Diastolic BP (n=22, 23, 22, 23)	71.1 mmHg	Standard Deviation 9.59
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Diastolic BP (n=22, 23, 22, 23)	69.7 mmHg	Standard Deviation 6.33
PF-04531083 2000 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Systolic BP (n=22, 23, 22, 23)	119.3 mmHg	Standard Deviation 10.52
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Systolic BP (n=22, 23, 22, 23)	126.7 mmHg	Standard Deviation 11.15
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Diastolic BP(n=21,23,22,22)	72.1 mmHg	Standard Deviation 5.56
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Systolic BP (n=22, 23, 22, 23)	124.0 mmHg	Standard Deviation 11.39
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Diastolic BP (n=22, 23, 22, 23)	72.5 mmHg	Standard Deviation 9.61
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Diastolic BP (n=22, 23, 22, 23)	71.4 mmHg	Standard Deviation 6.99
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Systolic BP(n=21,23,22,22 )	125.4 mmHg	Standard Deviation 11.14
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Diastolic BP (n=22, 23, 22, 23)	71.6 mmHg	Standard Deviation 6.75
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Systolic BP (n=22, 23, 22, 23)	122.4 mmHg	Standard Deviation 10.05
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Diastolic BP (n=22, 23, 22, 23)	67.7 mmHg	Standard Deviation 8.9
Ibuprofen 400 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Systolic BP (n=22, 23, 22, 23)	126.6 mmHg	Standard Deviation 14.4
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Diastolic BP(n=21,23,22,22)	72.3 mmHg	Standard Deviation 9.83
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Systolic BP (n=22, 23, 22, 23)	126.5 mmHg	Standard Deviation 10.22
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Screening: Diastolic BP (n=22, 23, 22, 23)	72.8 mmHg	Standard Deviation 8.31
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Systolic BP (n=22, 23, 22, 23)	128.0 mmHg	Standard Deviation 10.8
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 0: Diastolic BP (n=22, 23, 22, 23)	71.3 mmHg	Standard Deviation 9.1
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Systolic BP (n=22, 23, 22, 23)	124.1 mmHg	Standard Deviation 14.39
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 1: Diastolic BP (n=22, 23, 22, 23)	70.7 mmHg	Standard Deviation 11.51
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Systolic BP (n=22, 23, 22, 23)	122.2 mmHg	Standard Deviation 12.31
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 2: Diastolic BP (n=22, 23, 22, 23)	69.6 mmHg	Standard Deviation 8.48
Placebo	Supine Systolic and Diastolic Blood Pressure (BP)	Day 10-14 (Follow-up): Systolic BP(n=21,23,22,22 )	122.5 mmHg	Standard Deviation 10.18

Secondary

Time-specific Pain Intensity Difference (PID) Score

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	8 hours (n=10, 9, 15, 8)	1.00 units on a scale	Standard Deviation 0.47
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	Prior to RM (n=14, 16, 14, 16)	-0.57 units on a scale	Standard Deviation 0.51
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	4 hours (n=11, 10, 15, 10)	0.91 units on a scale	Standard Deviation 0.3
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	15 minutes (n=22, 23, 22, 23)	0.14 units on a scale	Standard Deviation 0.64
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	6 hours (n=11, 9, 15, 9)	0.91 units on a scale	Standard Deviation 0.3
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	45 minutes (n=22, 23, 22, 23)	0.23 units on a scale	Standard Deviation 0.69
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	1 hour (n=22, 23, 22, 23)	0.14 units on a scale	Standard Deviation 0.64
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	30 minutes (n=22, 23, 22, 23)	0.18 units on a scale	Standard Deviation 0.73
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	24 hours (n=8, 7, 8, 7)	1.63 units on a scale	Standard Deviation 0.52
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	1.5 hours (n=22, 23, 22, 23)	0.00 units on a scale	Standard Deviation 0.69
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	2 hours (n=15, 13, 20, 16)	0.13 units on a scale	Standard Deviation 0.64
PF-04531083 1000 mg	Time-specific Pain Intensity Difference (PID) Score	3 hours (n=11, 10, 15, 12)	0.82 units on a scale	Standard Deviation 0.4
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	30 minutes (n=22, 23, 22, 23)	0.35 units on a scale	Standard Deviation 0.78
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	3 hours (n=11, 10, 15, 12)	1.00 units on a scale	Standard Deviation 0.67
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	1 hour (n=22, 23, 22, 23)	0.17 units on a scale	Standard Deviation 0.83
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	6 hours (n=11, 9, 15, 9)	1.22 units on a scale	Standard Deviation 0.44
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	8 hours (n=10, 9, 15, 8)	1.22 units on a scale	Standard Deviation 0.67
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	4 hours (n=11, 10, 15, 10)	0.90 units on a scale	Standard Deviation 0.57
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	15 minutes (n=22, 23, 22, 23)	0.17 units on a scale	Standard Deviation 0.65
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	2 hours (n=15, 13, 20, 16)	0.69 units on a scale	Standard Deviation 0.48
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	1.5 hours (n=22, 23, 22, 23)	0.04 units on a scale	Standard Deviation 0.88
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	45 minutes (n=22, 23, 22, 23)	0.30 units on a scale	Standard Deviation 0.88
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	Prior to RM (n=14, 16, 14, 16)	-0.44 units on a scale	Standard Deviation 0.51
PF-04531083 2000 mg	Time-specific Pain Intensity Difference (PID) Score	24 hours (n=8, 7, 8, 7)	1.86 units on a scale	Standard Deviation 0.38
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	4 hours (n=11, 10, 15, 10)	1.20 units on a scale	Standard Deviation 0.56
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	15 minutes (n=22, 23, 22, 23)	0.18 units on a scale	Standard Deviation 0.39
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	30 minutes (n=22, 23, 22, 23)	0.41 units on a scale	Standard Deviation 0.67
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	45 minutes (n=22, 23, 22, 23)	0.59 units on a scale	Standard Deviation 0.67
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	1 hour (n=22, 23, 22, 23)	0.68 units on a scale	Standard Deviation 0.72
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	1.5 hours (n=22, 23, 22, 23)	0.68 units on a scale	Standard Deviation 0.78
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	2 hours (n=15, 13, 20, 16)	0.75 units on a scale	Standard Deviation 0.97
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	3 hours (n=11, 10, 15, 12)	1.20 units on a scale	Standard Deviation 0.68
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	6 hours (n=11, 9, 15, 9)	1.20 units on a scale	Standard Deviation 0.68
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	8 hours (n=10, 9, 15, 8)	1.20 units on a scale	Standard Deviation 0.56
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	24 hours (n=8, 7, 8, 7)	1.63 units on a scale	Standard Deviation 0.74
Ibuprofen 400 mg	Time-specific Pain Intensity Difference (PID) Score	Prior to RM (n=14, 16, 14, 16)	-0.29 units on a scale	Standard Deviation 0.61
Placebo	Time-specific Pain Intensity Difference (PID) Score	2 hours (n=15, 13, 20, 16)	0.44 units on a scale	Standard Deviation 0.96
Placebo	Time-specific Pain Intensity Difference (PID) Score	1.5 hours (n=22, 23, 22, 23)	0.26 units on a scale	Standard Deviation 1.01
Placebo	Time-specific Pain Intensity Difference (PID) Score	15 minutes (n=22, 23, 22, 23)	0.17 units on a scale	Standard Deviation 0.39
Placebo	Time-specific Pain Intensity Difference (PID) Score	8 hours (n=10, 9, 15, 8)	1.50 units on a scale	Standard Deviation 0.76
Placebo	Time-specific Pain Intensity Difference (PID) Score	1 hour (n=22, 23, 22, 23)	0.39 units on a scale	Standard Deviation 1.03
Placebo	Time-specific Pain Intensity Difference (PID) Score	45 minutes (n=22, 23, 22, 23)	0.35 units on a scale	Standard Deviation 0.83
Placebo	Time-specific Pain Intensity Difference (PID) Score	Prior to RM (n=14, 16, 14, 16)	-0.50 units on a scale	Standard Deviation 0.52
Placebo	Time-specific Pain Intensity Difference (PID) Score	24 hours (n=8, 7, 8, 7)	1.86 units on a scale	Standard Deviation 0.69
Placebo	Time-specific Pain Intensity Difference (PID) Score	4 hours (n=11, 10, 15, 10)	1.20 units on a scale	Standard Deviation 0.63
Placebo	Time-specific Pain Intensity Difference (PID) Score	3 hours (n=11, 10, 15, 12)	0.83 units on a scale	Standard Deviation 0.94
Placebo	Time-specific Pain Intensity Difference (PID) Score	30 minutes (n=22, 23, 22, 23)	0.35 units on a scale	Standard Deviation 0.71
Placebo	Time-specific Pain Intensity Difference (PID) Score	6 hours (n=11, 9, 15, 9)	1.44 units on a scale	Standard Deviation 0.53

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.

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	2 hours (n=15, 13, 20, 16)	1.07 units on a scale	Standard Deviation 0.96
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	Prior to RM (n=14, 16, 14, 16)	0.14 units on a scale	Standard Deviation 0.36
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	3 hours (n=11, 10, 15, 12)	2.27 units on a scale	Standard Deviation 0.79
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	4 hours (n=11, 10, 15, 10)	2.27 units on a scale	Standard Deviation 0.79
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	24 hours (n=8, 7, 8, 7)	3.63 units on a scale	Standard Deviation 0.52
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	30 minutes (n=22, 23, 22, 23)	0.82 units on a scale	Standard Deviation 0.85
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	6 hours (n=11, 9, 15, 9)	2.64 units on a scale	Standard Deviation 0.67
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	45 minutes (n=22, 23, 22, 23)	0.91 units on a scale	Standard Deviation 0.87
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	0 hours (n=22, 23, 22, 23)	0.00 units on a scale	Standard Deviation 0
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	1 hour (n=22, 23, 22, 23)	0.86 units on a scale	Standard Deviation 0.99
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	15 minutes (n=22, 23, 22, 23)	0.59 units on a scale	Standard Deviation 0.8
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	1.5 hours (n=22, 23, 22, 23)	0.82 units on a scale	Standard Deviation 0.91
PF-04531083 1000 mg	Time-specific Pain Relief (PR) Score	8 hours (n=10, 9, 15, 8)	2.70 units on a scale	Standard Deviation 0.82
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	2 hours (n=15, 13, 20, 16)	1.77 units on a scale	Standard Deviation 0.93
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	45 minutes (n=22, 23, 22, 23)	1.26 units on a scale	Standard Deviation 1.18
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	Prior to RM (n=14, 16, 14, 16)	0.25 units on a scale	Standard Deviation 0.58
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	24 hours (n=8, 7, 8, 7)	3.86 units on a scale	Standard Deviation 0.38
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	3 hours (n=11, 10, 15, 12)	2.30 units on a scale	Standard Deviation 1.06
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	30 minutes (n=22, 23, 22, 23)	1.04 units on a scale	Standard Deviation 1.07
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	0 hours (n=22, 23, 22, 23)	0.00 units on a scale	Standard Deviation 0
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	15 minutes (n=22, 23, 22, 23)	0.78 units on a scale	Standard Deviation 0.95
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	4 hours (n=11, 10, 15, 10)	2.20 units on a scale	Standard Deviation 0.92
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	1.5 hours (n=22, 23, 22, 23)	0.91 units on a scale	Standard Deviation 1.12
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	1 hour (n=22, 23, 22, 23)	1.13 units on a scale	Standard Deviation 1.06
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	8 hours (n=10, 9, 15, 8)	2.67 units on a scale	Standard Deviation 1.32
PF-04531083 2000 mg	Time-specific Pain Relief (PR) Score	6 hours (n=11, 9, 15, 9)	2.67 units on a scale	Standard Deviation 0.87
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	1 hour (n=22, 23, 22, 23)	1.73 units on a scale	Standard Deviation 1.28
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	8 hours (n=10, 9, 15, 8)	2.60 units on a scale	Standard Deviation 0.91
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	24 hours (n=8, 7, 8, 7)	3.38 units on a scale	Standard Deviation 0.74
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	30 minutes (n=22, 23, 22, 23)	1.23 units on a scale	Standard Deviation 1.23
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	Prior to RM (n=14, 16, 14, 16)	0.50 units on a scale	Standard Deviation 0.65
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	0 hours (n=22, 23, 22, 23)	0.00 units on a scale	Standard Deviation 0
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	45 minutes (n=22, 23, 22, 23)	1.55 units on a scale	Standard Deviation 1.22
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	6 hours (n=11, 9, 15, 9)	2.87 units on a scale	Standard Deviation 0.92
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	1.5 hours (n=22, 23, 22, 23)	1.77 units on a scale	Standard Deviation 1.38
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	2 hours (n=15, 13, 20, 16)	1.90 units on a scale	Standard Deviation 1.37
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	15 minutes (n=22, 23, 22, 23)	0.59 units on a scale	Standard Deviation 0.91
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	3 hours (n=11, 10, 15, 12)	2.73 units on a scale	Standard Deviation 0.96
Ibuprofen 400 mg	Time-specific Pain Relief (PR) Score	4 hours (n=11, 10, 15, 10)	2.87 units on a scale	Standard Deviation 0.92
Placebo	Time-specific Pain Relief (PR) Score	3 hours (n=11, 10, 15, 12)	2.25 units on a scale	Standard Deviation 1.06
Placebo	Time-specific Pain Relief (PR) Score	0 hours (n=22, 23, 22, 23)	0.00 units on a scale	Standard Deviation 0
Placebo	Time-specific Pain Relief (PR) Score	15 minutes (n=22, 23, 22, 23)	0.57 units on a scale	Standard Deviation 0.73
Placebo	Time-specific Pain Relief (PR) Score	30 minutes (n=22, 23, 22, 23)	1.04 units on a scale	Standard Deviation 1.02
Placebo	Time-specific Pain Relief (PR) Score	45 minutes (n=22, 23, 22, 23)	1.35 units on a scale	Standard Deviation 1.07
Placebo	Time-specific Pain Relief (PR) Score	1 hour (n=22, 23, 22, 23)	1.39 units on a scale	Standard Deviation 1.34
Placebo	Time-specific Pain Relief (PR) Score	1.5 hours (n=22, 23, 22, 23)	1.30 units on a scale	Standard Deviation 1.22
Placebo	Time-specific Pain Relief (PR) Score	2 hours (n=15, 13, 20, 16)	1.63 units on a scale	Standard Deviation 1.26
Placebo	Time-specific Pain Relief (PR) Score	6 hours (n=11, 9, 15, 9)	3.11 units on a scale	Standard Deviation 0.78
Placebo	Time-specific Pain Relief (PR) Score	4 hours (n=11, 10, 15, 10)	2.60 units on a scale	Standard Deviation 1.17
Placebo	Time-specific Pain Relief (PR) Score	8 hours (n=10, 9, 15, 8)	3.13 units on a scale	Standard Deviation 0.83
Placebo	Time-specific Pain Relief (PR) Score	24 hours (n=8, 7, 8, 7)	3.71 units on a scale	Standard Deviation 0.49
Placebo	Time-specific Pain Relief (PR) Score	Prior to RM (n=14, 16, 14, 16)	0.25 units on a scale	Standard Deviation 0.45

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.

Time frame: 1.5 to 24 hours

Arm	Measure	Value (MEDIAN)
PF-04531083 1000 mg	Time to First Use of Rescue Medication	4.8 hours
PF-04531083 2000 mg	Time to First Use of Rescue Medication	2.6 hours
Ibuprofen 400 mg	Time to First Use of Rescue Medication	11.1 hours
Placebo	Time to First Use of Rescue Medication	3.2 hours

Comparison: 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.90% CI: [0.6, 1.9]

Comparison: 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.90% CI: [0.7, 2.4]

Comparison: 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.90% CI: [0.4, 1.3]

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.

Time frame: 0 to 24 hours

Arm	Measure	Value (MEDIAN)
PF-04531083 1000 mg	Time to Onset of First Meaningful Pain Relief (PR)	3.0 hours
PF-04531083 2000 mg	Time to Onset of First Meaningful Pain Relief (PR)	4.9 hours
Ibuprofen 400 mg	Time to Onset of First Meaningful Pain Relief (PR)	3.3 hours
Placebo	Time to Onset of First Meaningful Pain Relief (PR)	3.5 hours

Comparison: 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.90% CI: [0.5, 2.1]

Comparison: 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.90% CI: [0.4, 1.8]

Comparison: 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.90% CI: [0.7, 2.9]

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.

Time frame: 0 to 24 hours

Arm	Measure	Value (MEDIAN)
PF-04531083 1000 mg	Time to Onset of First Perceptible Pain Relief (PR)	0.4 hours
PF-04531083 2000 mg	Time to Onset of First Perceptible Pain Relief (PR)	0.3 hours
Ibuprofen 400 mg	Time to Onset of First Perceptible Pain Relief (PR)	0.4 hours
Placebo	Time to Onset of First Perceptible Pain Relief (PR)	0.4 hours

Comparison: 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.90% CI: [0.5, 1.5]

Comparison: 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.90% CI: [0.7, 2.1]

Comparison: 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.90% CI: [0.6, 2]

Secondary

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

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

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

Arm	Measure	Group	Value (MEDIAN)
PF-04531083 1000 mg	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen	(R)-Ibuprofen	4.02 hours
PF-04531083 1000 mg	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen	(S)-Ibuprofen	4.02 hours

Secondary

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

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

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

Arm	Measure	Value (MEDIAN)
PF-04531083 1000 mg	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083	4.02 hours
PF-04531083 2000 mg	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083	6.00 hours

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.

Time frame: 0 to 24 hours

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04531083 1000 mg	Total Pain Relief (TOTPAR) Score From 0 to 24 Hours	21.8 units on a scale*hour	Standard Error 7.4
PF-04531083 2000 mg	Total Pain Relief (TOTPAR) Score From 0 to 24 Hours	20.7 units on a scale*hour	Standard Error 7.3
Ibuprofen 400 mg	Total Pain Relief (TOTPAR) Score From 0 to 24 Hours	30.8 units on a scale*hour	Standard Error 7.4
Placebo	Total Pain Relief (TOTPAR) Score From 0 to 24 Hours	21.5 units on a scale*hour	Standard Error 7.3

Comparison: 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.90% CI: [-15.6, 16.1]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

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

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

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

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

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

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

Maximum Observed Plasma Concentration (Cmax) of Ibuprofen

Maximum Observed Plasma Concentration (Cmax) of PF-04531083

Number of Participants With Clinically Significant Laboratory Test Abnormality

Number of Participants With Peak Pain Relief (PPR)

Number of Participants With Rescue Medication

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

Participant Global Evaluation of Study Medication

Participant Satisfaction Questionnaire

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

Supine Pulse Rate

Supine Systolic and Diastolic Blood Pressure (BP)

Time-specific Pain Intensity Difference (PID) Score

Time-specific Pain Relief (PR) Score

Time to First Use of Rescue Medication

Time to Onset of First Meaningful Pain Relief (PR)

Time to Onset of First Perceptible Pain Relief (PR)

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

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

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