Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01002573 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Fever, sponsored by Cumberland Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
118
Enrollment target
17
Study locations

NCT01002573 is a Phase 3 study of Fever that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 118 participants, below the 593-participant average among 18 other Fever trials with a reported enrollment target (80% lower). The trial reports 17 study locations across 12 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01002573, a Phase 3 study of Fever, has completed, sponsored by Cumberland Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
118 participants
Enrollment target
17
Study locations

Study 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 Studied

Interventions

  • DRUG ibuprofen
  • DRUG acetaminophen

Study Locations (17)

Texas

  • Children's Medical Center Dallas - Dallas
  • Children's Memorial Hermann Hospital - Houston
  • Texas Children's Hospital - Houston

California

  • Loma Linda University Medical Center - Loma Linda
  • Children's Hospital of Orange County - Orange

Florida

  • Jackson Memorial Hospital (U. Miami) - Miami
  • Florida Hospital - Orlando

Louisiana

  • Ochsner Clinic Foundation - New Orleans
  • LSU Health Sciences Center - Shreveport

Arizona

  • Maricopa Medical Center - Phoenix

District of Columbia

  • Howard University - Washington D.C.

Georgia

  • Joseph M. Still Burn Center - Augusta

Kentucky

  • Kosair Children's Hospital - Louisville

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2010-07
Est. Completion 2013-06
Phase Phase 3

Sponsor

Cumberland Pharmaceuticals

43 total trials

What the Registry Record Tells You About NCT01002573

The ClinicalTrials.gov registry entry for NCT01002573 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 593-participant average among 18 other Fever trials with a reported enrollment target (80% lower). The listed sponsor is Cumberland Pharmaceuticals, which has 43 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fever appearing as the primary indexed condition, and to 2 interventions - of which ibuprofen is the first listed.

NCT01002573 reports 17 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01002573 about?

NCT01002573 is a clinical study titled "Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients". 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.

What is the current status of trial NCT01002573?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2010-07. Estimated completion is 2013-06.

What conditions does trial NCT01002573 study?

This clinical trial studies the following conditions: Fever.

What interventions are being tested in trial NCT01002573?

The interventions under investigation include: ibuprofen (DRUG), acetaminophen (DRUG).

Who is sponsoring clinical trial NCT01002573?

This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01002573 being conducted?

This trial has 17 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Fever

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.