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

Completed · Phase 3 · Has a placebo group

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT00606489

Run by

Cumberland Pharmaceuticals

People needed

61

Starts

2007-11-01

Expected to finish

2009-05-01

Last updated by the study team

2011-08-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Adequate intravenous access
• Have fever, documented by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit)

You may not qualify if…

• Patients with electric burns
• Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever reducing medications within 4 hours prior to dosing
• Patients taking warfarin or lithium
• Active, clinically significant asthma
• History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), or COX-2 inhibitors
• Pregnant or nursing
• 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
• 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
• Have gastrointestional bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
• Have a platelet count less than 20,000 mm\^3
• Be on dialysis
• Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is acceptable)
• 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.)
• 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.)
• Have received another investigational drug within the past 30 days
• Be otherwise unsuitable for the study in the opinion of the investigator

Where it is running

• Orlando Regional Medical Center — Orlando, Florida, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Naik's Hospital — Baroda, Kothi, India
• Lokmanya Tilak Municipal Medical College — Mumbai, Sion, India
• Surya Hospitals Pvt. Ltd — Pune, India

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.