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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00606489
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Information provided by:
Cumberland Pharmaceuticals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Burns
Interventions: Drug: Caldolor
Drug: Placebo

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 21   40   61 
[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 
[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

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

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

Responsible Party: Amy Rock, Ph.D., Senior Manager, Regulatory Affairs, Cumberland Pharmaceuticals Inc. Identifier: NCT00606489     History of Changes
Other Study ID Numbers: CPI-CL-010
First Submitted: January 22, 2008
First Posted: February 4, 2008
Results First Submitted: April 4, 2011
Results First Posted: August 11, 2011
Last Update Posted: August 11, 2011