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Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients

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ClinicalTrials.gov Identifier: NCT00606489
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Sponsor:
Information provided by:
Cumberland Pharmaceuticals

Brief Summary:
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.

Condition or disease Intervention/treatment Phase
Burns Drug: Caldolor Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients
Study Start Date : November 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Placebo
Experimental: 2 Drug: Caldolor
800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours



Primary Outcome Measures :
  1. Temperature [ Time Frame: 0 to 24 hours ]
    Area under the curve temperature from baseline to hour 24 following initiation of treatment.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with second and/or third degree thermal burns covering more than 10 percent total body surface area (including face) with anticipated hospital stay greater than 72 hours.
  2. Adequate intravenous access
  3. Have fever, documented by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit)

Exclusion Criteria:

  1. Patients with electric burns
  2. Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever reducing medications within 4 hours prior to dosing
  3. Patients taking warfarin or lithium
  4. Active, clinically significant asthma
  5. History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), or COX-2 inhibitors
  6. Pregnant or nursing
  7. 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 aneurism or central nervous system mass lesion
  8. Have a history of congenital bleeding diathesis (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
  9. Have gastrointestional bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
  10. Have a platelet count less than 20,000 mm^3
  11. Be on dialysis
  12. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is acceptable)
  13. Inability 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 [IRB]), and agree to abide by the study restrictions (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)
  14. Refusal to provide written authorization for use and disclosure of protected health information (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)
  15. Have received another investigational drug within the past 30 days
  16. Be otherwise unsuitable for the study in the opinion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606489


Locations
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
India
Naik's Hospital
Baroda, Kothi, India, 390001
Lokmanya Tilak Municipal Medical College
Mumbai, Sion, India, 400022
Surya Hospitals Pvt. Ltd
Pune, India, 411 011
Sponsors and Collaborators
Cumberland Pharmaceuticals

Responsible Party: Amy Rock, Ph.D., Senior Manager, Regulatory Affairs, Cumberland Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00606489     History of Changes
Other Study ID Numbers: CPI-CL-010
First Posted: February 4, 2008    Key Record Dates
Results First Posted: August 11, 2011
Last Update Posted: August 11, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action