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

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.

Timeline

Start

2010-01

Primary completion

2011-05

Completion

2011-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Ibuprofen Sodium; p = 0.228; Least-squares (LS) mean difference 8.33 (95% CI -7.94 to 24.60); ANOVA; NCT01035346 ↗

Publications

• Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.

Drugs

Indications