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Prader-Willi Syndrome and Appetite

This study has been terminated.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175305
First received: September 9, 2005
Last updated: October 29, 2007
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients with Prader-Willi syndrome, confirmed by genetic testing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00175305     History of Changes
Other Study ID Numbers: C04-0007, W04-0007
Study First Received: September 9, 2005
Last Updated: October 29, 2007
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 22, 2013