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

This study has been completed.
Sponsor:
Information provided by:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00606489
First received: January 22, 2008
Last updated: July 18, 2011
Last verified: July 2011

January 22, 2008
July 18, 2011
November 2007
May 2009   (final data collection date for primary outcome measure)
Temperature [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
To evaluate the efficacy of Amelior compared to placebo when administered every 6 hours for 24 hours on reducing fever [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00606489 on ClinicalTrials.gov Archive Site
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Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Burns
  • 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
  • Drug: Placebo
    Placebo
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: Caldolor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
India,   United States
 
NCT00606489
CPI-CL-010
Yes
Amy Rock, Ph.D., Senior Manager, Regulatory Affairs, Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals
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Cumberland Pharmaceuticals
July 2011

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