Trial Information
Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Changes in body composition (lean body mass and fat mass) measured by dual energy X-ray absorptiometry (DXA)
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Charlotte Hoybye, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Endocrinology and Diabetology, Karolinska Hospital
Authority:
Sweden: Medical Products Agency
Study ID:
CH1234
NCT ID:
NCT00372125
Start Date:
April 2005
Completion Date:
March 2010
Related Keywords:
- Prader-Willi Syndrome
- Prader-Willi syndrome
- Growth hormone
- Body composition
- Prader-Willi Syndrome