CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 118 enrolled
Drug / intervention
ibuprofen +1 moredrug
Likely dose
ibuprofen 10 mg/kgfrom 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/NCT01002573
NCT01002573Phase 3Completed
CompareCT.gov

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

Cumberland Pharmaceuticals·interventional·Posted Oct 27, 2009·Updated Nov 7, 2016

In Brief

A Phase 3 clinical trial evaluating ibuprofen and acetaminophen for Fever. Completed, enrolled 118 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFever
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2009
Enrollment StartJul 1, 2010
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.7 years ago

Interventions

ibuprofendrug

Ibuprofen, 10 mg/kg

acetaminophendrug

Acetaminophen, 10mg/kg