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

Fever Clinical Trial

Official title:

A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002573
• Other study ID #: CPI-CL-012
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2009
• Last updated: July 7, 2014
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever

Intervention

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

Locations

Country	Name	City	State
United States	Joseph M. Still Burn Center	Augusta	Georgia
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Children's Memorial Hermann Hospital	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	LeBonheur Children's Hospital	Memphis	Tennessee
United States	Jackson Memorial Hospital (U. Miami)	Miami	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Children's Hospital of Orange County	Orange	California
United States	Florida Hospital	Orlando	Florida
United States	Maricopa Medical Center	Phoenix	Arizona
United States	LSU Health Sciences Center	Shreveport	Louisiana
United States	Staten Island University Hospital	Staten Island	New York
United States	The Children's Hospital at Saint Francis	Tulsa	Oklahoma
United States	Howard University	Washington DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fever Reduction		2 hours	No