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

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Antipyretics; Ibuprofen

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.