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

This study has been completed.
Sponsor:
Information provided by:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01131000
First received: May 24, 2010
Last updated: May 25, 2010
Last verified: May 2010

May 24, 2010
May 25, 2010
June 2002
August 2005   (final data collection date for primary outcome measure)
Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01131000 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fever
  • Drug: Ibuprofen
    Intravenous ibuprofen, 100 mg, Single-dose
  • Drug: Ibuprofen
    Intravenous ibuprofen, 200mg, single dose
  • Drug: Ibuprofen
    Intravenous ibuprofen, 400 mg, Single-dose
  • Other: Normal Saline
    Normal Saline, 100 ml, Single-dose
    Other Name: 0.9 % NaCL; 0.9 % Sodium Chloride
  • Experimental: Ibuprofen
    Interventions:
    • Drug: Ibuprofen
    • Drug: Ibuprofen
    • Drug: Ibuprofen
  • Placebo Comparator: Saline
    Normal Saline
    Intervention: Other: Normal Saline
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. Epub 2010 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
August 2005
August 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Thailand
 
NCT01131000
CPI-CL-004
Yes
A. J. Kazimi, Chief Executive Office, Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals
Not Provided
Study Chair: Gordon Bernard, M.D. Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP