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Pain
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Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Sponsored by Cumberland Pharmaceuticals

About this trial

Last updated 5 years ago

Study ID

CPI-CL-022

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
Up to 6 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial 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.

What are the participation requirements?

Yes

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.

No

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.