Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
1 other identifier
interventional
118
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2010
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
November 7, 2016
CompletedNovember 7, 2016
September 1, 2016
2.9 years
October 26, 2009
July 29, 2016
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fever Reduction
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)
0 to 2 hours post-dose
Secondary Outcomes (6)
Change From Baseline in Temperature After the First 30 Minutes of Treatment
30 minutes following treatment
Change From Baseline in Temperature After the First 60 Minutes of Treatment
60 minutes following treatment
Change in Temperature
4 hours following treatment
Change From Baseline in Temperature After the First Four Hours of Treatment
0 to 4 hours post-dose
Time to Afebrility (in Hours)
4 Hour post treatment
- +1 more secondary outcomes
Study Arms (2)
ibuprofen
EXPERIMENTALIbuprofen, 10 mg/kg
Acetaminophen
ACTIVE COMPARATORAcetaminophen, 10mg/kg
Interventions
Acetaminophen, 10mg/kg
Eligibility Criteria
You may qualify if:
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
- Be between birth (28 weeks to \< 40 weeks gestational age) to ≤ 16 years of age.
- Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).
You may not qualify if:
- Have inadequate intravenous access.
- Have received antipyretic drug therapy within 2 hours before dosing.
- Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
- Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
- Have a fever due to hyperthermia.
- Pregnant or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Jackson Memorial Hospital (U. Miami)
Miami, Florida, 33136, United States
Florida Hospital
Orlando, Florida, 32804, United States
Joseph M. Still Burn Center
Augusta, Georgia, 30909, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2483, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
The Children's Hospital at Saint Francis
Tulsa, Oklahoma, 74136, United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.
PMID: 28143430DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager, Clinical Operations
- Organization
- Cumberland Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Art Wheeler, M.D.
Cumberland Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2009
First Posted
October 27, 2009
Study Start
July 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
November 7, 2016
Results First Posted
November 7, 2016
Record last verified: 2016-09