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Burn Healing and Analgesia With Propranolol (BURN HELP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00934947
First received: July 6, 2009
Last updated: October 7, 2014
Last verified: October 2014
Results First Received: May 7, 2012  
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
Conditions: Burns
Pain
Interventions: Drug: Propranolol
Drug: Placebo
Drug: Propanolol

  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
No text entered.

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
Sugar Pill Identical to active drug in sight, taste, and smell.
Propranolol, Propanolol ER Identical to sugar pill in sight, taste, and smell.

Participant Flow:   Overall Study
    Sugar Pill     Propranolol, Propanolol ER  
STARTED     23     22  
COMPLETED     23     20  
NOT COMPLETED     0     2  
Adverse Event                 0                 2  



  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
Sugar Pill Identical to active drug in sight, taste, and smell.
Propranolol, Propanolol ER Identical to sugar pill in sight, taste, and smell.
Total Total of all reporting groups

Baseline Measures
    Sugar Pill     Propranolol, Propanolol ER     Total  
Number of Participants  
[units: participants]
  23     22     45  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     23     22     45  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32  ± 11     31  ± 9     32  ± 10  
Gender  
[units: participants]
     
Female     4     7     11  
Male     19     15     34  
Region of Enrollment  
[units: participants]
     
United States     23     22     45  



  Outcome Measures

1.  Primary:   Overall Pain Trajectory Slopes   [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ]

2.  Secondary:   Sleep Quality   [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Itch Symptoms   [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Anxiety Symptoms   [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Samuel McLean
Organization: UNC Department of Anesthesiology
phone: 919-966-7315
e-mail: smclean@aims.unc.edu


No publications provided


Responsible Party: Samuel McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00934947     History of Changes
Other Study ID Numbers: 09-0681
Study First Received: July 6, 2009
Results First Received: May 7, 2012
Last Updated: October 7, 2014
Health Authority: United States: Institutional Review Board