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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Infection

Treatments: Drug: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01035346

AH-09-12

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Ibuprofen

B

Placebo Comparator group

Treatment:

Drug: Placebo