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Prader-Willi Syndrome and Appetite

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00175305
First Posted: September 15, 2005
Last Update Posted: October 31, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of British Columbia
  Purpose
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 Intervention Phase
Hyperphagia Prader-Willi Syndrome Drug: Sandostatin LAR Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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

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

Estimated Enrollment: 10
Study Start Date: August 2004
Study Completion Date: October 2007
  Show Detailed Description

  Eligibility

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
Criteria

Inclusion Criteria:

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


Locations
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
Investigators
Principal Investigator: Jean-Pierre Chanoine, MD University of British Columbia
  More Information

ClinicalTrials.gov Identifier: NCT00175305     History of Changes
Other Study ID Numbers: C04-0007
W04-0007
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by University of British Columbia:
Prader-Willi Syndrome
Somatostatin
Ghrelin
Obesity
Hyperphagia
Hyperphagia in Prader-Willi syndrome

Additional relevant MeSH terms:
Syndrome
Prader-Willi Syndrome
Hyperphagia
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Somatostatin
Octreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents