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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: Completed Phase 3 study of Fever, sponsored by Cumberland Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
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 |
What the finished NCT01002573 record still lists
NCT01002573 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 593-participant average among 18 other Fever trials with a reported enrollment target (80% lower).
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 lists 17 locations in 12 states (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.
Learn More About Clinical Trials
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.
Where NCT01002573's enrollment target sits among peer trials
118 11th of 18 higher than 8 of 18 other Fever trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fever trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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