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

NCT01002573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2016-11-07

Study results available
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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.

Conditions

Interventions

DRUG

ibuprofen

Ibuprofen, 10 mg/kg

DRUG

acetaminophen

Acetaminophen, 10mg/kg

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Art Wheeler, M.D. · Cumberland Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002573 on ClinicalTrials.gov