NCT00606489

Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients

A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	Caldolor	800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-02-04
• Last updated: 2011-08-11
• Results posted: 2011-08-11

Locations

5 sites across 2 countries: United States, India