Status:
COMPLETED
Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The aim of this study is to study the effects of GH on body composition, lipid and glucose metabolism, physical performance and safety aspects in adults with PWS.The patients are randomized to either ...
Detailed Description
OBJECTIVE(S): Prader Willi syndrome (PWS) is a multi-symptomatic genetic disorder associated with abnormalities in the growth hormone (GH)-insulin-like-growth factor (IGF)-I axis and in the body comp...
Eligibility Criteria
Inclusion
- Genetically verified PWS diagnosis (by methylation and FISH test.)
- Between 18 and 50 years old
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the treatment of the subject.)
Exclusion
- Known or suspected allergy to GH preparation.
- Previous participation in this trial.
- GH treatment within the last 1 years
- Malignancy or other serious diseases (ex severe cardiovascular diseases, severe infections)
- Sexhormone treatment initiated within the last year
- Pregnancy
- Untreated respiratory impairment, untreated sleep apnoea or untreated respiratory infection.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00372125
Start Date
April 1 2005
End Date
March 1 2010
Last Update
September 13 2016
Active Locations (3)
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1
Center for rare Diseases, Department of Pediatrics, Skejby University Hospital
Aarhus N, Denmark, 8200
2
Endokrinologisk seksjon, Med Avd, Rikshospitalet
Oslo, Norway
3
Department of Endocrinology and Diabetology, Karolinska Hospital
Stockholm, Sweden, 171 76