CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Caldolor +1 moredrug
Likely dose
Caldolor 800 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00606489
NCT00606489Phase 3Completed
CompareCT.gov

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

Cumberland Pharmaceuticals·interventional·Posted Feb 4, 2008·Updated Aug 11, 2011

In Brief

A Phase 3 clinical trial evaluating Caldolor and Placebo for Burns. Completed, enrolled 61 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesIndia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 4, 2008
Enrollment StartNov 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.4 years ago

Interventions

Caldolordrug

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

Placebodrug

Placebo