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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
Results First Received: April 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Burns
Interventions: Drug: Caldolor
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were patients admitted to the study centers who had second and third degree thermal burns covering more than 10% total body surface area, including the face.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo (250 Milliliters Normal Saline) No text entered.
800mg Intravenous Ibuprofen No text entered.

Participant Flow:   Overall Study
    Placebo (250 Milliliters Normal Saline)     800mg Intravenous Ibuprofen  
STARTED     21     40  
COMPLETED     21     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo (250 Milliliters Normal Saline) No text entered.
800mg Intravenous Ibuprofen No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo (250 Milliliters Normal Saline)     800mg Intravenous Ibuprofen     Total  
Number of Participants  
[units: participants]
  21     40     61  
Age  
[units: years]
Mean ± Standard Deviation
  30  ± 11.9     33  ± 10.8     32  ± 11.2  
Age, Customized  
[units: participants]
     
<=12 years old     0     0     0  
>12 years old     21     40     61  
Gender  
[units: participants]
     
Female     11     25     36  
Male     10     15     25  
Region of Enrollment  
[units: participants]
     
United States     7     9     16  
India     14     31     45  



  Outcome Measures

1.  Primary:   Temperature   [ Time Frame: 0 to 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Amy Rock, Doctor of Philosophy (Ph.D.)
Organization: Cumberland Pharmaceuticals
phone: 6152550068
e-mail: arock@cumberlandpharma.com


No publications provided


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
Study First Received: January 22, 2008
Results First Received: April 4, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration