NCT00175305

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

September 9, 2005

Last Update Submit

October 29, 2007

Conditions

HyperphagiaPrader-Willi Syndrome

Keywords

Prader-Willi SyndromeSomatostatinGhrelinObesityHyperphagiaHyperphagia in Prader-Willi syndrome

Outcome Measures

Primary Outcomes (1)

  • Changes in ghrelin concentrations during a test meal

    8 to 10 AM

Secondary Outcomes (1)

  • Change in weight, behaviour and food intake

Interventions

Sandostatin LARDRUG

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V5Z 1L8, Canada

Location

MeSH Terms

Conditions

HyperphagiaPrader-Willi SyndromeObesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Jean-Pierre Chanoine, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

August 1, 2004

Study Completion

October 1, 2007

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

CA(1)