Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01035346
• Collaborator: (none)
• Enrollment: 16
• Locations: 5
• Arms: 2
• Duration (Months): 15.9
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Ibuprofen; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Ibuprofen; Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
Placebo Comparator: B	Drug: Placebo; Single dose of a placebo

Outcome Measures

Primary Outcome Measures

1. Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6) [0 to 6 hours]

   STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.

Secondary Outcome Measures

1. Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8) [0 to 4, 0 to 8 hours]

   STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.

2. Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 [Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours]

   Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.

3. Time to Treatment Failure [0 to 8 hours]

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

4. Cumulative Percentage of Participants With Treatment Failure [0.25, 0.5, 1, 2, 4, 6, 8 hours]

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

5. Global Assessment of Study Medication as an Antipyretic [8 hours]

   Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.

6. Rating of Study Medication Relative to Usual Medication [8 hours]

   Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection.

• Oral temperature measurement from 100 to 104 degrees Fahrenheit.

• Onset of fever 3 days or less.

• Otherwise good health.

Exclusion Criteria:

• Fever secondary to a chronic underlying medical condition or serious infection.

• Currently taking antibiotics or antivirals.

• Currently taking any medication which may interfere with the assessment of fever.

• Pregnancy or breast-feeding.

• Any serious medical or psychiatric disorder.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Cypress	California	United States	90630
2	Pfizer Investigational Site	Westlake Village	California	United States	91361
3	Pfizer Investigational Site	Omaha	Nebraska	United States	68144
4	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15241
5	Pfizer Investigational Site	Salt Lake City	Utah	United States	84124

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: NCT01035346
• Other Study ID Numbers: AH-09-12
• First Posted: Dec 18, 2009
• Last Update Posted: Aug 21, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Pfizer: Fever; antipyretic; uncomplicated acute viral infection; uncomplicated acute bacterial infections
• Additional relevant MeSH terms: Infections; Communicable Diseases; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.	Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Period Title: Overall Study
STARTED	7	9
COMPLETED	7	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Ibuprofen Sodium	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	7	9	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (15.3)	37.3 (17.9)	34.8 (16.5)
Sex: Female, Male (Count of Participants)
Female	2 28.6%	4 44.4%	6 37.5%
Male	5 71.4%	5 55.6%	10 62.5%
Body Temperature (Degrees Fahrenheit) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Degrees Fahrenheit]	100.99 (0.83)	100.58 (0.66)	100.76 (0.74)

Outcome Measures

1. Primary Outcome

Title	Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
Description	STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
Time Frame	0 to 6 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	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.
Measure Participants	7	9
Mean (Standard Deviation) [Degrees Fahrenheit]	3.0 (6.3)	10.8 (4.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.228
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Least-squares (LS) mean difference
	Estimated Value	8.33
	Confidence Interval	(2-Sided) 95%; -7.94 to 24.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)
Description	STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
Time Frame	0 to 4, 0 to 8 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	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.
Measure Participants	7	9
STEMPD 0-4	1.7 (3.9)	6.7 (2.9)
STEMPD 0-8	5.7 (9.4)	13.4 (7.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	STEMPD 0-4: 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	0.171
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	5.99
	Confidence Interval	(2-Sided) 95%; -3.99 to 15.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	STEMPD 0-8: 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	0.354
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	8.96
	Confidence Interval	(2-Sided) 95%; -14.78 to 32.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8
Description	Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
Time Frame	Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	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.
Measure Participants	7	9
0.25 hours	0.4 (0.4)	0.4 (0.3)
0.5 hours	0.5 (0.4)	0.7 (0.4)
1 hour	0.3 (0.7)	1.2 (0.7)
2 hours	0.8 (1.0)	1.9 (0.9)
4 hours	0.3 (1.5)	2.0 (0.9)
6 hours	0.7 (1.5)	2.1 (1.3)
8 hours	1.3 (1.7)	1.3 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	0.25 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	0.576
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature 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%; -0.84 to 0.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	0.5 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	0.502
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; -0.50 to 0.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

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	0.116
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; -0.51 to 3.12
	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	0.161
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.58
	Confidence Interval	(2-Sided) 95%; -0.98 to 4.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	4 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	0.215
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.87
	Confidence Interval	(2-Sided) 95%; -1.66 to 5.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	6 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	0.388
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; -2.18 to 4.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	8 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	0.849
	Comments	p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; -3.98 to 4.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. 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 use of rescue medication, whichever comes first.
Time Frame	0 to 8 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	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.
Measure Participants	7	9
Median (95% Confidence Interval) [hours]	NA	NA

5. 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	0.25, 0.5, 1, 2, 4, 6, 8 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	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.
Measure Participants	7	9
0.25 hours	0.0 0%	0.0 0%
0.5 hours	0.0 0%	0.0 0%
1 hour	0.0 0%	0.0 0%
2 hours	0.0 0%	0.0 0%
4 hours	0.0 0%	0.0 0%
6 hours	0.0 0%	0.0 0%
8 hours	0.0 0%	11.1 123.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.378
	Comments	p-value was calculated using CMH general association test using table scores. 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	11.11
	Confidence Interval	(2-Sided) 95%; -10.67 to 32.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Global Assessment of Study Medication as an Antipyretic
Description	Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	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.
Measure Participants	7	9
Mean (Standard Deviation) [units on a scale]	1.8 (1.5)	2.5 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.324
	Comments	p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; -0.30 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Rating of Study Medication Relative to Usual Medication
Description	Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ibuprofen Sodium
Arm/Group Description	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.
Measure Participants	7	9
Mean (Standard Deviation) [units on a scale]	1.5 (1.4)	2.4 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ibuprofen Sodium
	Comments	Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.210
	Comments	p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; -0.12 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Placebo		Ibuprofen Sodium
Arm/Group Description	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.
All Cause Mortality
	Placebo		Ibuprofen Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Ibuprofen Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Ibuprofen Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/7 (14.3%)		3/9 (33.3%)
General disorders
Cold sweat	0/7 (0%)		1/9 (11.1%)
Fatigue	0/7 (0%)		1/9 (11.1%)
Malaise	0/7 (0%)		1/9 (11.1%)
Pain	1/7 (14.3%)		0/9 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/7 (14.3%)		0/9 (0%)
Skin and subcutaneous tissue disorders
Pruritus	0/7 (0%)		1/9 (11.1%)

Limitations/Caveats

Definitive conclusion could not be made due to early termination of study, due to low enrollment rate, and small number of enrolled participants.

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.