NCT01002573

Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

Detailed description

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.

Conditions

• Fever

Interventions

Type	Name	Description
DRUG	ibuprofen	Ibuprofen, 10 mg/kg
DRUG	acetaminophen	Acetaminophen, 10mg/kg

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2009-10-27
• Last updated: 2016-11-07
• Results posted: 2016-11-07

Locations

17 sites across 1 country: United States