NCT01131000

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

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The primary objective of this study is to evaluate the efficacy of a single 400 mg dose of intravenous ibuprofen on reducing fever greater than or equal to 101.0ºF (38.3ºC), as compared with the efficacy of parallel placebo treatment.

Conditions

• Fever

Interventions

Type	Name	Description
DRUG	Ibuprofen	Intravenous ibuprofen, 100 mg, Single-dose
DRUG	Ibuprofen	Intravenous ibuprofen, 200mg, single dose
DRUG	Ibuprofen	Intravenous ibuprofen, 400 mg, Single-dose
OTHER	Normal Saline	Normal Saline, 100 ml, Single-dose

Timeline

• Start date: 2002-06-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2010-05-26
• Last updated: 2010-05-26

Locations

11 sites across 3 countries: United States, Australia, Thailand