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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Infection

In brief

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.

Key facts

Study ID

NCT01035346

Run by

Pfizer

People needed

16

Starts

2010-01-01

Expected to finish

2011-05-01

Last updated by the study team

2012-08-21

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Cypress, California, United States
• Pfizer Investigational Site — Westlake Village, 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

Full record on ClinicalTrials.gov

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