Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

Completed · Phase 3

Conditions studied: Fever

In brief

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

Key facts

Study ID

NCT01131000

Run by

Cumberland Pharmaceuticals

People needed

123

Starts

2002-06-01

Expected to finish

2005-08-01

Last updated by the study team

2010-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Have fever secondary to blood or drug reaction
• Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
• Be receiving treatment with corticosteroids (Patients who are expected to receive corticosteroids during the Treatment Period or through Hour 120 of the Post-treatment Period are not eligible.)
• Have neurogenic fever
• Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL, or be receiving nephrotoxic drugs
• Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved
• Have received another investigational drug within the past 30 days
• Become afebrile (temperature below 101.0ºF [38.3ºC]) before dosing and not redevelop fever entry criteria during this hospitalization
• Be otherwise unsuitable for the study, in the opinion of the Investigator

Where it is running

• Orlando Regional Medical Center — Orlando, Florida, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Methodist Healthcare - University Hospital — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Skyline Medical Center — Nashville, Tennessee, United States
• Ben Taub General Hospital — Houston, Texas, United States
• Newcastle Mater Misericordiae Hospital — New Lambton, New South Wales, Australia
• Flinders Medical Centre — Adelaide, South Australia, Australia
• Mahidol University Siriraj Hospital — Bangkok, Thailand

Full record on ClinicalTrials.gov

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