Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00175305 |
Date of registration:
|
09/09/2005 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Prader-Willi Syndrome and Appetite
|
Scientific title:
|
Effect of Somatostatin on Ghrelin Concentrations, Food Seeking Behaviour and Weight in Patients With Prader-Willi Syndrome |
Date of first enrolment:
|
August 2004 |
Target sample size:
|
10 |
Recruitment status: |
Terminated |
URL:
|
http://clinicaltrials.gov/show/NCT00175305 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
Phase:
|
Phase 3
|
|
Countries of recruitment
|
Canada
| | | | | | | |
Contacts
|
Name:
|
Jean-Pierre Chanoine, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University of British Columbia |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with Prader-Willi syndrome, confirmed by genetic testing
Age minimum:
10 Years
Age maximum:
17 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Prader-Willi Syndrome
|
Hyperphagia
|
Intervention(s)
|
Drug: Sandostatin LAR
|
Primary Outcome(s)
|
Changes in ghrelin concentrations during a test meal
[Time Frame: 8 to 10 AM]
|
Secondary Outcome(s)
|
Change in weight, behaviour and food intake
|
Secondary ID(s)
|
W04-0007
|
C04-0007
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|