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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01131000
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 26, 2010
Information provided by:
Cumberland Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Fever Drug: Ibuprofen Other: Normal Saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients
Study Start Date : June 2002
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Ibuprofen Drug: Ibuprofen
Intravenous ibuprofen, 100 mg, Single-dose

Drug: Ibuprofen
Intravenous ibuprofen, 200mg, single dose

Drug: Ibuprofen
Intravenous ibuprofen, 400 mg, Single-dose

Placebo Comparator: Saline
Normal Saline
Other: Normal Saline
Normal Saline, 100 ml, Single-dose
Other Name: 0.9 % NaCL; 0.9 % Sodium Chloride

Primary Outcome Measures :
  1. Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen. [ Time Frame: 4 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be hospitalized
  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:

  1. Be less than 18 years of age
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01131000

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United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, North Carolina
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Methodist Healthcare - University Hospital
Memphis, Tennessee, United States, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Skyline Medical Center
Nashville, Tennessee, United States, 37207
United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Australia, New South Wales
Newcastle Mater Misericordiae Hospital
New Lambton, New South Wales, Australia, 2305
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Mahidol University Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Cumberland Pharmaceuticals
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Study Chair: Gordon Bernard, M.D. Cumberland Pharmaceuticals, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: A. J. Kazimi, Chief Executive Office, Cumberland Pharmaceuticals Inc. Identifier: NCT01131000    
Other Study ID Numbers: CPI-CL-004
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010
Additional relevant MeSH terms:
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Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action