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

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: National Center for Research Resources (NCRR); National Institutes of Health (NIH); Novartis
• Treatments: Octreotide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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