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Prader-Willi Syndrome and Appetite

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ClinicalTrials.gov Identifier: NCT00175305
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : October 31, 2007
Information provided by:
University of British Columbia

Brief Summary:
Excessive weight gain is a cardinal feature of Prader-Willi syndrome (PWS) for which there is presently no effective treatment. It is caused by increased appetite, decreased perception of satiety and obsessive and compulsive behaviour towards food. Ghrelin is a powerful appetite-stimulating hormone. Patients with PWS have markedly elevated ghrelin levels, suggesting that it may be responsible for the increased food intake. The goal of the study is to determine whether treatment with somatostatin (Sandostatin), a hormone that inhibits ghrelin, is an effective treatment for the prevention and treatment of weight excess in patients with PWS.

Condition or disease Intervention/treatment Phase
Hyperphagia Prader-Willi Syndrome Drug: Sandostatin LAR Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Somatostatin on Ghrelin Concentrations, Food Seeking Behaviour and Weight in Patients With Prader-Willi Syndrome
Study Start Date : August 2004
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Octreotide

Primary Outcome Measures :
  1. Changes in ghrelin concentrations during a test meal [ Time Frame: 8 to 10 AM ]

Secondary Outcome Measures :
  1. Change in weight, behaviour and food intake

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients with Prader-Willi syndrome, confirmed by genetic testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175305

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Canada, British Columbia
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Jean-Pierre Chanoine, MD University of British Columbia
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ClinicalTrials.gov Identifier: NCT00175305    
Other Study ID Numbers: C04-0007
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by University of British Columbia:
Prader-Willi Syndrome
Hyperphagia in Prader-Willi syndrome
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Nutrition Disorders
Signs and Symptoms, Digestive
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents