A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients

Cumberland Pharmaceuticals11 sites in 3 countries123 target enrollmentJune 2002

ConditionsFever

InterventionsIbuprofen Normal Saline

DrugsIbuprofen

Overview

Phase: Phase 3
Intervention: Ibuprofen
Conditions: Fever
Sponsor: Cumberland Pharmaceuticals
Enrollment: 123
Locations: 11
Primary Endpoint: Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.

Detailed Description

The primary objective of this study is to evaluate the efficacy of a single 400 mg dose of intravenous ibuprofen on reducing fever greater than or equal to 101.0ºF (38.3ºC), as compared with the efficacy of parallel placebo treatment.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

August 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cumberland Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Be hospitalized
•Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC)
•Have adequate intravenous access
•Have the ability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board), and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria

•Be less than 18 years of age
•Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing
•Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors
•Be pregnant or nursing
•Have a history of severe head trauma that required current hospitalization, intracranial surgery, or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
•Weigh less than 40 kg
•Have a history of congenital bleeding diatheses (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction, including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
•Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
•Have a platelet count less than 30,000/mm3
•Be receiving full dose anticoagulation therapy