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

Phase 3

Completed

• Conditions: Fever
• Interventions: Drug: ibuprofen; Drug: acetaminophen

• Registration Number: NCT01002573
• Lead Sponsor: Cumberland Pharmaceuticals

Brief 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.

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.

Study Timeline

• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Study Start: 2010-07
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Disposition First Submitted: 2014-07-07
• Disposition First Submitted QC: 2014-07-07
• Disposition First Posted: 2014-07-09
• Results First Submitted: 2016-07-29
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Results First Posted: 2016-11-06
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 101.0 ºF (38.3 ºC).

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen	ibuprofen	Ibuprofen, 10 mg/kg
Acetaminophen	acetaminophen	Acetaminophen, 10mg/kg

Primary Outcome Measures

Name	Time	Method
Fever Reduction	0 to 2 hours post-dose	Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Temperature After the First Four Hours of Treatment	0 to 4 hours post-dose	Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)
Change From Baseline in Temperature After the First 30 Minutes of Treatment	30 minutes following treatment	Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.
Change From Baseline in Temperature After the First 60 Minutes of Treatment	60 minutes following treatment	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.
Time to Afebrility (in Hours)	4 Hour post treatment	Tme to afebrility (temperature less than 100.4 ºF \[38 ºC\]) in patients receiving intravenous ibuprofen and APAP.
Change in Temperature	4 hours following treatment	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose	4 Hours Post-Dose	Number of Afebrile and Febrile Subject at 4 Hours Following Treatment

Trial Locations

Locations (17)

Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Children's Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Joseph M. Still Burn Center; 🇺🇸 Augusta, Georgia, United States

The Children's Hospital at Saint Francis; 🇺🇸 Tulsa, Oklahoma, United States

LeBonheur Children's Hospital; 🇺🇸 Memphis, Tennessee, United States

Children's Medical Center Dallas; 🇺🇸 Dallas, Texas, United States

LSU Health Sciences Center; 🇺🇸 Shreveport, Louisiana, United States

Howard University; 🇺🇸 Washington DC, District of Columbia, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States

Maricopa Medical Center; 🇺🇸 Phoenix, Arizona, United States

Jackson Memorial Hospital (U. Miami); 🇺🇸 Miami, Florida, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States