Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01077973
• Collaborator: (none)
• Enrollment: 200
• Arms: 3
• Duration (Months): 7

Study Details

Study Description

Brief Summary

This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Novel Ibuprofen; Drug: Standard Ibuprofen; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A	Drug: Novel Ibuprofen; Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
Active Comparator: Treatment B	Drug: Standard Ibuprofen; Single-dose of standard ibuprofen (400mg) plus placebo
Placebo Comparator: Treatment C	Drug: Placebo; Single-dose of placebo

Outcome Measures

Primary Outcome Measures

1. Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet [0 to 3 hours]

   SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).

2. Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet [0 to 3 hours]

   Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.

Secondary Outcome Measures

1. Time to Onset of Meaningful Relief: Remaining Comparisons [0 to 3 hours]

   Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.

2. Time to Confirmed First Perceptible Relief [0 to 3 hours]

   Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".

3. Pain Relief Rating (PRR) [1, 2, 3 hours]

   PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.

4. Pain Intensity Difference (PID) [1, 2, 3 hours]

   PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).

5. Sum of Pain Relief Rating and Pain Intensity Difference (PRID) [1, 2, 3 hours]

   PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).

6. Time-weighted Sum of Pain Intensity Difference (SPID) [0 to 2, 0 to 3 hours]

   SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).

7. Time-weighted Sum of Pain Relief Rating (TOTPAR) [0 to 2, 0 to 3 hours]

   TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.

8. Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) [0 to 2, 0 to 3 hours]

   SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).

9. Cumulative Percentage of Participants With Meaningful Relief [0.5, 1, 2, 3 hours]

   Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.

10. Cumulative Percentage of Participants With Confirmed First Perceptible Relief [0.5, 1, 2, 3 hours]

    Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".

11. Time to Treatment Failure [0 to 3 hours]

    Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.

12. Cumulative Percentage of Participants With Treatment Failure [0 to 3 hours]

    Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.

13. Cumulative Percentage of Participants With Complete Relief [1, 2, 3 hours]

    Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and females at least 18 years to 65 years of age

• A diagnosis of an episodic tension-type headache, as defined by the International Headache Society

• A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics

Exclusion Criteria:

• Pregnancy or breast-feeding

• Alcohol or substance abuse

• Any serious medical or psychiatric disorder

• History of stomach ulcers, stomach bleed, or other bleeding disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01077973
• Other Study ID Numbers: AH-09-11
• First Posted: Mar 1, 2010
• Last Update Posted: Aug 20, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Pfizer: Headache
• Additional relevant MeSH terms: Tension-Type Headache; Headache; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Period Title: Overall Study
STARTED	41	79	80
COMPLETED	41	79	80
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)	Total
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Total of all reporting groups
Overall Participants	41	79	80	200
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	42.9 (13.5)	43.4 (13.3)	40.9 (14.0)	42.3 (13.6)
Sex: Female, Male (Count of Participants)
Female	28 68.3%	55 69.6%	55 68.8%	138 69%
Male	13 31.7%	24 30.4%	25 31.3%	62 31%
Number of Participants with Pain Severity Score (Number) [Number]
Moderately severe	30 73.2%	58 73.4%	59 73.8%	147 73.5%
Severe	11 26.8%	21 26.6%	21 26.3%	53 26.5%

Outcome Measures

1. Primary Outcome

Title	Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
Description	SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time Frame	0 to 3 hours

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
Measure Participants	41	79
Mean (Standard Deviation) [Units on a scale]	11.2 (4.9)	10.8 (5.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.299
	Comments	p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Least-square (LS) mean difference
	Estimated Value	-1.12
	Confidence Interval	(2-Sided) 95%; -3.23 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
Description	Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
Time Frame	0 to 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	79	80
Median (95% Confidence Interval) [Minutes]	50.3	55.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.193
	Comments	p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	Proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.52 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Time to Onset of Meaningful Relief: Remaining Comparisons
Description	Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
Time Frame	0 to 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
Median (95% Confidence Interval) [Minutes]	48.2	50.3	55.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.304
	Comments	p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	Proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.936
	Comments	p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	Proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Time to Confirmed First Perceptible Relief
Description	Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".
Time Frame	0 to 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
Median (95% Confidence Interval) [Minutes]	42.3	41.7	43.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.072
	Comments	p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	Proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.41 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.652
	Comments	p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	Proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.58 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.108
	Comments	p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	Proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.49 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Pain Relief Rating (PRR)
Description	PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Time Frame	1, 2, 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
1 hour	1.9 (1.0)	1.9 (1.2)	1.6 (1.0)
2 hours	2.6 (1.1)	2.5 (1.2)	2.4 (1.2)
3 hours	3.0 (1.2)	2.8 (1.3)	2.7 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.402
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.65 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.407
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.991
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) 95%; -0.38 to 0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.313
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.621
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95%; -0.62 to 0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.533
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.54 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.352
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.573
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.657
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.54 to 0.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Pain Intensity Difference (PID)
Description	PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).
Time Frame	1, 2, 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
1 hour	0.9 (0.6)	0.9 (0.6)	0.8 (0.6)
2 hours	1.3 (0.7)	1.3 (0.7)	1.2 (0.8)
3 hours	1.5 (0.8)	1.5 (0.9)	1.4 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.382
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.36 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.242
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.39 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.720
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.235
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -0.43 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.630
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95%; -0.34 to 0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.393
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.382
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.46 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.995
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.287
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.41 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
Description	PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Time Frame	1, 2, 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
1 hour	2.8 (1.5)	2.8 (1.8)	2.4 (1.5)
2 hours	3.9 (1.7)	3.7 (1.9)	3.6 (1.9)
3 hours	4.5 (2.0)	4.3 (2.1)	4.1 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.377
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 95%; -0.98 to 0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.324
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -1.01 to 0.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.902
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -0.52 to 0.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.273
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -1.17 to 0.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.616
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.94 to 0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.471
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -0.85 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.356
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -1.24 to 0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.722
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -1.00 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.493
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -0.94 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Time-weighted Sum of Pain Intensity Difference (SPID)
Description	SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).
Time Frame	0 to 2, 0 to 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
SPID 0-2	2.2 (1.3)	2.2 (1.3)	2.0 (1.3)
SPID 0-3	3.8 (2.0)	3.6 (2.1)	3.4 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.259
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	SPID 0-2: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.378
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	SPID 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.762
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.45 to 0.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.281
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -1.17 to 0.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	SPID 0-3: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.582
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.97 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	SPID 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.523
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.83 to 0.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Time-weighted Sum of Pain Relief Rating (TOTPAR)
Description	TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Time Frame	0 to 2, 0 to 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
TOTPAR 0-2	4.5 (2.0)	4.4 (2.3)	4.1 (2.0)
TOTPAR 0-3	7.5 (3.1)	7.2 (3.5)	6.8 (3.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.327
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -1.35 to 0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	TOTPAR 0-2: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.489
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -1.21 to 0.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	TOTPAR 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.726
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.88 to 0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.320
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -2.09 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	TOTPAR 0-3: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.506
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -1.86 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	TOTPAR 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.691
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -1.38 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
Description	SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time Frame	0 to 2, 0 to 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
SPRID 0-2	6.7 (3.1)	6.5 (3.4)	6.1 (3.2)
SPRID 0-3	11.2 (4.9)	10.8 (5.3)	10.2 (5.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.292
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -2.07 to 0.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	SPRID 0-2: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.439
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.53
	Confidence Interval	(2-Sided) 95%; -1.87 to 0.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	SPRID 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.733
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -1.31 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	SPRID 0-3: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.526
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.68
	Confidence Interval	(2-Sided) 95%; -2.80 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	SPRID 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.624
	Comments	p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 95%; -2.19 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Cumulative Percentage of Participants With Meaningful Relief
Description	Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
Time Frame	0.5, 1, 2, 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
0.5 hours	14.6 35.6%	17.7 22.4%	10.0 12.5%
1 hour	65.9 160.7%	58.2 73.7%	60.0 75%
2 hours	85.4 208.3%	79.7 100.9%	81.3 101.6%
3 hours	85.4 208.3%	81.0 102.5%	82.5 103.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.672
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	3.02
	Confidence Interval	(2-Sided) 95%; -11.03 to 17.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	0.5 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.467
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-4.47
	Confidence Interval	(2-Sided) 95%; -17.61 to 8.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.164
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	7.55
	Confidence Interval	(2-Sided) 95%; -2.96 to 18.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.427
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-7.52
	Confidence Interval	(2-Sided) 95%; -25.96 to 10.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.537
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-5.66
	Confidence Interval	(2-Sided) 95%; -23.57 to 12.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.813
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-1.83
	Confidence Interval	(2-Sided) 95%; -16.88 to 13.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.455
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-5.50
	Confidence Interval	(2-Sided) 95%; -19.24 to 8.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.570
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-4.02
	Confidence Interval	(2-Sided) 95%; -17.63 to 9.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.792
	Comments	p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-1.65
	Confidence Interval	(2-Sided) 95%; -13.80 to 10.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.556
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-4.25
	Confidence Interval	(2-Sided) 95%; -17.82 to 9.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.689
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-2.77
	Confidence Interval	(2-Sided) 95%; -16.24 to 10.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.786
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-1.65
	Confidence Interval	(2-Sided) 95%; -13.45 to 10.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Description	Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".
Time Frame	0.5, 1, 2, 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
0.5 hours	24.4 59.5%	30.4 38.5%	28.8 36%
1 hour	80.5 196.3%	67.1 84.9%	72.5 90.6%
2 hours	85.4 208.3%	81.0 102.5%	82.5 103.1%
3 hours	85.4 208.3%	81.0 102.5%	82.5 103.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.480
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	6.06
	Confidence Interval	(2-Sided) 95%; -10.86 to 22.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	0.5 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.612
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	4.34
	Confidence Interval	(2-Sided) 95%; -12.55 to 21.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.839
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	1.47
	Confidence Interval	(2-Sided) 95%; -12.60 to 15.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.130
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-13.20
	Confidence Interval	(2-Sided) 95%; -29.40 to 2.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.331
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-7.83
	Confidence Interval	(2-Sided) 95%; -23.39 to 7.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.450
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-5.50
	Confidence Interval	(2-Sided) 95%; -19.59 to 8.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.556
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-4.25
	Confidence Interval	(2-Sided) 95%; -17.82 to 9.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.689
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-2.77
	Confidence Interval	(2-Sided) 95%; -16.24 to 10.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.786
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-1.65
	Confidence Interval	(2-Sided) 95%; -13.45 to 10.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.556
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-4.25
	Confidence Interval	(2-Sided) 95%; -17.82 to 9.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.689
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-2.77
	Confidence Interval	(2-Sided) 95%; -16.24 to 10.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.786
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-1.65
	Confidence Interval	(2-Sided) 95%; -13.45 to 10.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Time to Treatment Failure
Description	Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.
Time Frame	0 to 3 hours

Outcome Measure Data

Analysis Population Description

Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	0	0	0

14. Secondary Outcome

Title	Cumulative Percentage of Participants With Treatment Failure
Description	Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Time Frame	0 to 3 hours

Outcome Measure Data

Analysis Population Description

Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	0	0	0

15. Secondary Outcome

Title	Cumulative Percentage of Participants With Complete Relief
Description	Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Time Frame	1, 2, 3 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Arm/Group Title	Placebo	Ibuprofen Sodium	Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.	Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Measure Participants	41	79	80
1 hour	2.4 5.9%	6.3 8%	1.3 1.6%
2 hours	17.1 41.7%	21.5 27.2%	15.0 18.8%
3 hours	41.5 101.2%	40.5 51.3%	35.0 43.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.355
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	3.89
	Confidence Interval	(2-Sided) 95%; -3.33 to 11.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.623
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-1.21
	Confidence Interval	(2-Sided) 95%; -6.62 to 4.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.094
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	5.10
	Confidence Interval	(2-Sided) 95%; -0.90 to 11.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.565
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	4.43
	Confidence Interval	(2-Sided) 95%; -10.43 to 19.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.765
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-2.09
	Confidence Interval	(2-Sided) 95%; -16.15 to 11.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.288
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	6.47
	Confidence Interval	(2-Sided) 95%; -5.43 to 18.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.928
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95%; -20.00 to 18.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.495
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-6.40
	Confidence Interval	(2-Sided) 95%; -25.14 to 12.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ibuprofen Sodium, Ibuprofen (Motrin IB)
	Comments	3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.477
	Comments	p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	5.46
	Confidence Interval	(2-Sided) 95%; -9.66 to 20.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Placebo		Ibuprofen Sodium		Ibuprofen (Motrin IB)
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.		Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.		Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
All Cause Mortality
	Placebo		Ibuprofen Sodium		Ibuprofen (Motrin IB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Ibuprofen Sodium		Ibuprofen (Motrin IB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/79 (0%)		0/80 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Ibuprofen Sodium		Ibuprofen (Motrin IB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/79 (0%)		0/80 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.