Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

NCT01131000 ↗

Phase 3 Completed 123 enrolled Cumberland Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.

Timeline

Start: 2002-06
Primary completion: 2005-08
Completion: 2005-08

Outcome

Met primary endpoint

paper At four hours, the number (percentage) with T<101.0 degrees F was: Placebo n = 9/28 (32%); 100 mg IV ibuprofen n = 19/31 (61%), P = 0.0264; PMID 20591173 ↗

Publications

Morris PE, Promes JT, Guntupalli KK, Wright PE, Arons MM. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibuprofen	Small molecule	100 mg	Intravenous
Subject	Ibuprofen	Small molecule	200 mg	Intravenous
Subject	Ibuprofen	Small molecule	400 mg	Intravenous

Indications

No indication recorded.