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

Pfizer1 site in 1 country16 target enrollmentJanuary 2010

ConditionsInfection

InterventionsIbuprofen Placebo

DrugsIbuprofen Placebo

Overview

Phase: Phase 3
Intervention: Ibuprofen
Conditions: Infection
Sponsor: Pfizer
Enrollment: 16
Locations: 1
Primary Endpoint: Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

May 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

A

Intervention: Ibuprofen

B

Intervention: Placebo

Outcomes

Primary Outcomes

Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)

Time Frame: 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 Outcomes

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)
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)
Time to Treatment Failure(0 to 8 hours)
Cumulative Percentage of Participants With Treatment Failure(0.25, 0.5, 1, 2, 4, 6, 8 hours)
Global Assessment of Study Medication as an Antipyretic(8 hours)
Rating of Study Medication Relative to Usual Medication(8 hours)