Know Cancer

or
forgot password

Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome


N/A
18 Years
50 Years
Open (Enrolling)
Both
Prader-Willi Syndrome

Thank you

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

Name

Location