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Efficacy and Safety Study of Amelior in Hospitalized Adult and Pediatric Burn Patients

This study is currently recruiting participants.
Verified by Cumberland Pharmaceuticals, September 2008

Sponsored by: Cumberland Pharmaceuticals
Information provided by: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00606489
  Purpose

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


Condition Intervention Phase
Burns
Drug: Amelior
Drug: Placebo
Phase III

MedlinePlus related topics:   Burns    Fever   

Drug Information available for:   Ibuprofen    Dexibuprofen   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients

Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   60
Study Start Date:   November 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator Drug: Placebo
Placebo
2: Experimental Drug: Amelior
800 mg of IVIb (patients > 12 years of age) or 10 mg/kg (patients < 12 years; maximum of 400 mg) q 6 hrs

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Patients with 2nd and/or 3rd degree thermal burns covering more than 10 percent total body surface area (including face) with anticipated hospital stay >72 hours.
  2. Adequate IV access
  3. Have fever, documented by temperature greater than or equal to 38.0°C (100.4°F)

Exclusion Criteria:

  1. Patients with electric burns
  2. Use of acetaminophen, 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 IVIb, 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 CNS mass lesion
  8. Have a history of congenital bleeding diathesis (eg 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 GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
  10. Have a platelet count less than 20,000mm3
  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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606489

Locations
United States, Florida
Orlando Regional Medical Center     Recruiting
      Orlando, Florida, United States
      Contact: Karen Safcsak, RN, BSN     321-841-8596     Toby.Safcsak@orhs.org    
      Principal Investigator: John T Promes, M.D.            
United States, North Carolina
Wake Forest University Health Sciences     Recruiting
      Winston-Salem, North Carolina, United States, 27157
      Contact: Kim East, TN     336-716-4155     kieast@wfubmc.edu    
      Principal Investigator: Peter Morris, M.D.            
India
Surya Hospitals Pvt. Ltd     Recruiting
      Pune, India, 411 011
      Contact: Naresh Jain, M.D.     020-24450050        
      Contact: Sudhakar R Madhukar, M.D.     99220-63514        
      Principal Investigator: Sudhakar R Madhukar, M.D.            
      Principal Investigator: Jaisingh K Shinde, M.D.            
India, Kothi
Naik's Hospital     Recruiting
      Baroda, Kothi, India, 390001
      Contact: Ankita Shah, M.D.     91-982434788        
      Principal Investigator: Himanshu Naik, M.D.            
      Principal Investigator: Vibha Naik, M.D.            
India, Sion
Lokmanya Tilak Municipal Medical College     Not yet recruiting
      Mumbai, Sion, India, 400022
      Contact: Madhuri Gore, M.D.     022-24076381        
      Principal Investigator: Madhuri Gore, M.D.            

Sponsors and Collaborators
Cumberland Pharmaceuticals
  More Information


Responsible Party:   Cumberland Pharmaceuticals Inc. ( Amy Rock, Ph.D., Senior Manager, Regulatory Affairs )
Study ID Numbers:   CPI-CL-010
First Received:   January 22, 2008
Last Updated:   September 23, 2008
ClinicalTrials.gov Identifier:   NCT00606489
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Fever
Burns
Ibuprofen
Wounds and Injuries
Disorders of Environmental Origin
Pain

ClinicalTrials.gov processed this record on November 06, 2008




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