Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Cumberland Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Fever

Pain

Treatments

Drug: Ibuprofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT02583399

CPI-CL-022

Details and patient eligibility

About

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Full description

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Enrollment

30 patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
Have a clinical indication of pain or fever.
Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.

Exclusion criteria

Have inadequate intravenous access.
Have an uncorrected ductus dependent congenital heart disease.
Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
Have a current history of uncorrected hypovolemia or acute renal disease.
Have a current history of acute liver disease.
Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to dosing. Have received another investigational drug within the past 30 days.
Be otherwise unsuitable for the study, in the opinion of the Investigator.