Status:
TERMINATED
Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
5-21 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate over a 6 month period the effect of octreotide therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning calories, bioma...
Detailed Description
Obesity continues to be a prevalent health concern affecting every race of the American population. According to data from the World Health Organization, 54% of U.S. adults are overweight (body mass i...
Eligibility Criteria
Inclusion
- Diagnosis of PWS confirmed by chromosome analysis
- Ages 5 years to 21 years
- BMI for age ≥ (greater-than or equal to)85th percentile
- Written informed consent and assent obtained and willingness to comply with the study schedule and procedures
- Free T4, Thyroid stimulating hormone (TSH) values in the normal range (either endogenous or with thyroxine replacement)
Exclusion
- Patients with any other clinically significant disease that would have an impact on body composition, including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
- Concomitant use of an investigational drug or Octreotide in the past year
- Use of steroids for longer than 7 days within the past 30 days
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00399893
Start Date
December 1 2006
End Date
September 1 2010
Last Update
July 24 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710