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

This study is currently recruiting participants.
Verified January 2013 by Cumberland Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01002573
First received: October 26, 2009
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Fever
U.S. FDA Resources

Further study details as provided by Cumberland Pharmaceuticals:

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

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002573

  Show 31 Study Locations
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: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Pediatric
Fever

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Ibuprofen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
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 June 18, 2013