Overview

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

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cumberland Pharmaceuticals
Treatments:
Ibuprofen
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