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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01002573
First received: October 26, 2009
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Fever
Drug: ibuprofen
Drug: acetaminophen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Fever Reduction [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ibuprofen
Ibuprofen, 10 mg/kg
Drug: ibuprofen
Ibuprofen, 10 mg/kg
Active Comparator: Acetaminophen
Acetaminophen, 10mg/kg
Drug: acetaminophen
Acetaminophen, 10mg/kg
Other Names:
  • APAP
  • paracetamol

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
  2. Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
  3. Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC).

Exclusion Criteria:

  1. Have inadequate intravenous access.
  2. Have received antipyretic drug therapy within 2 hours before dosing.
  3. Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
  4. Have received another investigational drug within the past 30 days.
  5. Be otherwise unsuitable for the study, in the opinion of the Investigator.
  6. Have a fever due to hyperthermia.
  7. Pregnant or nursing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002573

Locations
United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, District of Columbia
Howard University
Washington DC, District of Columbia, United States, 20060
United States, Florida
Jackson Memorial Hospital (U. Miami)
Miami, Florida, United States, 33136
Florida Hospital
Orlando, Florida, United States, 32804
United States, Georgia
Joseph M. Still Burn Center
Augusta, Georgia, United States, 30909
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121-2483
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, Oklahoma
The Children's Hospital at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Tennessee
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art Wheeler, M.D. Cumberland Pharmaceuticals Inc
  More Information

No publications provided

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01002573     History of Changes
Other Study ID Numbers: CPI-CL-012
Study First Received: October 26, 2009
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Pediatric
Fever

Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014