drugset / Trial / NCT00225706

A Study of Caldolor in Hospitalized Febrile Pediatric Patients

NCT00225706

Phase 3 Completed Cumberland Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a target temperature of 98.6ºF \[37.0ºC\]).

Timeline

Start
2005-10
Primary completion
2007-08
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule

Indications

No indication recorded.