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

Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131000
• Other study ID #: CPI-CL-004
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2010
• Last updated: May 25, 2010
• Start date: June 2002
• Est. completion date: August 2005

Study information

• Verified date: May 2010
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever

Intervention

Drug:
• Ibuprofen
Intravenous ibuprofen, 100 mg, Single-dose
• Ibuprofen
Intravenous ibuprofen, 200mg, single dose
• Ibuprofen
Intravenous ibuprofen, 400 mg, Single-dose

Other:
• Normal Saline
Normal Saline, 100 ml, Single-dose

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.		4 hours	No