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

Official Title: “A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection 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.

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.

Intervention(s) in this Clinical Trial

• Drug: ibuprofen
  • Ibuprofen, 10 mg/kg
• Drug: acetaminophen
  • Acetaminophen, 10mg/kg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: ibuprofen
  • Ibuprofen, 10 mg/kg
• Active Comparator: Acetaminophen
  • Acetaminophen, 10mg/kg

Primary Measures

• Fever Reduction
  • Time Frame: 2 hours
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Cumberland Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Art Wheeler, M.D. Study Director Cumberland Pharmaceuticals Inc  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01002573

Study ID Number: CPI-CL-012

ClinicalTrials.gov Identifier: NCT01002573

Health Authority: United States: Food and Drug Administration