A MULTI-CENTER, RANDOMIZED, OPEN-LABEL, PARALLEL, ACTIVE-COMPARATOR TRIAL TO DETERMINE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF INTRAVENOUS IBUPROFEN IN PEDIATRIC PATIENTS
This multi-center, randomized, open-label, parallel, active comparator clinical study will assess the efficacy, safety, and pharmacokinetics of ibuprofen administered intravenously to hospitalized febrile pediatric patients less than or equal to 16 years of age. Eligible patients will be randomized in a 1:1 ratio to receive one of two treatments:
Treatment Group 1: Initial single dose of 10.0 mg/kg intravenous ibuprofen followed by dosing as needed (maximum 400 mg per dose and maximum 2400 mg daily) or
Treatment Group 2: Initial single dose of 10.0 mg/kg acetaminophen, oral solution or suppository, followed by dosing as needed (maximum 650 mg per dose and maximum 3900 mg daily).
Two hundred patients (100 patients in each treatment group) will be randomized with efforts to randomize at least 50 patients in each group being randomized in the age group of birth to and amp;lt; 6 months of age and at least 6 patients being randomized from each of the following age groups: 6 months to and amp;lt; 2 years of age; 2 years to and amp;lt; 6 years of age and 6 years to ≤16 years.
The study duration will be up to 144 hours, with a single initial dose of CTM administered. Four hours following the initial dose, additional doses of CTM may be administered as needed (PRN), as determined by the investigator, during the 120 hour Treatment Period. Assessments of temperature, vital signs, laboratory measurements and AEs will be performed during the Treatment Period, and safety monitoring will continue for an additional 24 hours during the Post-Treatment Period. The intent of this study is to demonstrate the efficacy, safety and PK of intravenous ibuprofen for treating pediatric febrile patients.
To be considered eligible to participate in this study, a patient must meet the following 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 ≥6 months 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). (Temperature measurements will be performed utilizing the tympanic route).