Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients
NCT ID: NCT01131000
Last Updated: 2010-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2002-06-30
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ibuprofen
Ibuprofen
Intravenous ibuprofen, 100 mg, Single-dose
Ibuprofen
Intravenous ibuprofen, 200mg, single dose
Ibuprofen
Intravenous ibuprofen, 400 mg, Single-dose
Saline
Normal Saline
Normal Saline
Normal Saline, 100 ml, Single-dose
Interventions
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Ibuprofen
Intravenous ibuprofen, 100 mg, Single-dose
Ibuprofen
Intravenous ibuprofen, 200mg, single dose
Ibuprofen
Intravenous ibuprofen, 400 mg, Single-dose
Normal Saline
Normal Saline, 100 ml, Single-dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC)
3. Have adequate intravenous access
4. 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
2. Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing
3. Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors
4. Be pregnant or nursing
5. 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
6. Weigh less than 40 kg
7. 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
8. Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
9. Have a platelet count less than 30,000/mm3
10. Be receiving full dose anticoagulation therapy
11. Have fever secondary to blood or drug reaction
12. Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
13. 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.)
14. Have neurogenic fever
15. Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL, or be receiving nephrotoxic drugs
16. Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved
17. Have received another investigational drug within the past 30 days
18. Become afebrile (temperature below 101.0ºF \[38.3ºC\]) before dosing and not redevelop fever entry criteria during this hospitalization
19. Be otherwise unsuitable for the study, in the opinion of the Investigator
18 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Cumberland Pharmaceuticals Inc.
Principal Investigators
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Gordon Bernard, M.D.
Role: STUDY_CHAIR
Cumberland Pharmaceuticals, Inc.
Locations
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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
Countries
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References
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Morris PE, Promes JT, Guntupalli KK, Wright PE, Arons MM. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30.
Other Identifiers
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CPI-CL-004
Identifier Type: -
Identifier Source: org_study_id
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