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.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Drug: Ibuprofen; Drug: Ibuprofen; Drug: Ibuprofen; Other: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton, New South Wales, Australia, 2305
      • Newcastle Mater Misericordiae Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Flinders Medical Centre
• Thailand
  • Bangkok, Thailand, 10700
    • Mahidol University Siriraj Hospital
• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Moses H. Cone Memorial Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist Healthcare - University Hospital
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37207
      • Skyline Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 0.9 % NaCL; 0.9 % Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen.	4 hours

Collaborators and Investigators

• Sponsor: Cumberland Pharmaceuticals
• Investigators: Study Chair: Gordon Bernard, M.D., Cumberland Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 26, 2010
• Last Update Submitted That Met QC Criteria: May 25, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: CPI-CL-004