Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
This study is currently recruiting participants.
Verified January 2013 by Cumberland Pharmaceuticals
Information provided by (Responsible Party):
First received: October 26, 2009
Last updated: January 18, 2013
Last verified: January 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
Primary Outcome Measures:
- Fever Reduction [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
Ibuprofen, 10 mg/kg
Ibuprofen, 10 mg/kg
Active Comparator: Acetaminophen
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 as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.
|Ages Eligible for Study:
||up to 16 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
- Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
- Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC).
- Have inadequate intravenous access.
- Have received antipyretic drug therapy within 2 hours before dosing.
- Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
- Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
- Have a fever due to hyperthermia.
- Pregnant or nursing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002573
||Art Wheeler, M.D.
||Cumberland Pharmaceuticals Inc
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 26, 2009
||January 18, 2013
||United States: Food and Drug Administration
Keywords provided by Cumberland Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Body Temperature Changes
Signs and Symptoms
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Molecular Mechanisms of Pharmacological Action