Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients
A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients
1 other identifier
interventional
123
3 countries
11
Brief Summary
The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2002
Typical duration for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedMay 26, 2010
May 1, 2010
3.2 years
May 24, 2010
May 25, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.
4 hours
Study Arms (2)
Ibuprofen
EXPERIMENTALSaline
PLACEBO COMPARATORNormal Saline
Interventions
Normal Saline, 100 ml, Single-dose
Eligibility Criteria
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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Methodist Healthcare - University Hospital
Memphis, Tennessee, 38104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Skyline Medical Center
Nashville, Tennessee, 37207, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Newcastle Mater Misericordiae Hospital
New Lambton, New South Wales, 2305, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Mahidol University Siriraj Hospital
Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 20591173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gordon Bernard, M.D.
Cumberland Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 26, 2010
Study Start
June 1, 2002
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
May 26, 2010
Record last verified: 2010-05