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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 3

Conditions

Infection

Treatments

Drug: Ibuprofen
Drug: Placebo

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

16 participants in 2 patient groups, including a placebo group

A
Experimental group
Treatment:
Drug: Ibuprofen
B
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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