Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01002573

Public ClinicalTrials.gov record NCT01002573. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 3:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01002573
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cumberland Pharmaceuticals
Industry
Enrollment
118 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2010 (Type not available)
Primary completion
Jun 2013 (Actual)
Completion
Jun 2013 (Actual)
Last update posted
Nov 7, 2016

2010 – 2013

United States locations

U.S. sites
17
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Maricopa Medical Center Phoenix Arizona 85008 —
Loma Linda University Medical Center Loma Linda California 92354 —
Children's Hospital of Orange County Orange California 92868 —
Howard University Washington D.C. District of Columbia 20060 —
Jackson Memorial Hospital (U. Miami) Miami Florida 33136 —
Florida Hospital Orlando Florida 32804 —
Joseph M. Still Burn Center Augusta Georgia 30909 —
Kosair Children's Hospital Louisville Kentucky 40202 —
Ochsner Clinic Foundation New Orleans Louisiana 70121-2483 —
LSU Health Sciences Center Shreveport Louisiana 71103 —
Children's Hospital of Michigan Detroit Michigan 48201 —
Staten Island University Hospital Staten Island New York 10305 —
The Children's Hospital at Saint Francis Tulsa Oklahoma 74136 —
LeBonheur Children's Hospital Memphis Tennessee 38103 —
Children's Medical Center Dallas Dallas Texas 75235 —
Children's Memorial Hermann Hospital Houston Texas 77030 —
Texas Children's Hospital Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01002573, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 7, 2016 · Synced Oct 26, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01002573 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →