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

Infection Clinical Trial

Official title:

Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01035346
• Other study ID #: AH-09-12
• Status: Terminated
• Phase: Phase 3
• First received: December 8, 2009
• Last updated: July 13, 2012
• Start date: January 2010
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Drug:
• Ibuprofen
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
• Placebo
Single dose of a placebo

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Cypress	California
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)	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.	0 to 6 hours	No
Secondary	Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)	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.	0 to 4, 0 to 8 hours	No
Secondary	Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8	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.	Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours	No
Secondary	Time to Treatment Failure	Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.	0 to 8 hours	No
Secondary	Cumulative Percentage of Participants With Treatment Failure	Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.	0.25, 0.5, 1, 2, 4, 6, 8 hours	No
Secondary	Global Assessment of Study Medication as an Antipyretic	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.	8 hours	No
Secondary	Rating of Study Medication Relative to Usual Medication	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.	8 hours	No

External Links

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