Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)

Stopped early · Not applicable · Has a placebo group

Conditions studied: Prader-Willi Syndrome

In brief

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, biomarkers of weight regulation and growth hormone markers in children and young Adults with Prader-Willi Syndrome(PWS).

Key facts

Study ID

NCT00399893

Run by

Duke University

People needed

5

Starts

2006-12-01

Expected to finish

2010-09-01

Last updated by the study team

2014-07-24

Who can join

Age: 5 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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