Clinical trial NCT01131000: Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fever
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Memphis
country: United States
facility: Methodist Healthcare - University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Skyline Medical Center
state: Tennessee
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: New Lambton
country: Australia
facility: Newcastle Mater Misericordiae Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Bangkok
country: Thailand
facility: Mahidol University Siriraj Hospital
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Gordon Bernard, M.D.
role: STUDY_CHAIR
References:
citation: 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.