Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
NCT01002573 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01002573
The ClinicalTrials.gov registry entry for NCT01002573 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cumberland Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01002573 reports 17 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01002573?
The interventions under investigation include: ibuprofen (DRUG), acetaminophen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01002573?
This trial is sponsored by Cumberland Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.