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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2016 |
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Main ID: |
NCT00372125 |
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Date of registration:
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05/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome
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Scientific title:
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Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00372125 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Norway
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Sweden
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Contacts
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Name:
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Jens S Christiansen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Århus University Hospital, Denmark |
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Name:
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Charlotte Hoybye, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Endocrinology and Diabetology, Karolinska Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Intervention(s)
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Drug: Norditropin SimpleXx
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Primary Outcome(s)
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Changes in body composition (lean body mass and fat mass) measured by dual energy X-ray absorptiometry (DXA)
[Time Frame: 36 months]
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Secondary Outcome(s)
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Quality of life estimated by questionnaires
[Time Frame: 36 months]
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Effects on forced expiratory volume (Peakflow)
[Time Frame: 36 months]
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Effects on free and total IGF-I, IGF-binding protein (BP)-1 and 3
[Time Frame: 36 months]
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Activity of daily living measured a.m. Guralnik
[Time Frame: 36 months]
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Bone mineral density measured by DXA
[Time Frame: 36 months]
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Effects on body composition measured with bioimpedance
[Time Frame: 36 months]
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Effects on haemoglobin (Hb), leucocyte and thrombocyte counts, FSH, LH, estradiol, Testosterone, inhibin B, TSH and Thyroxine
[Time Frame: 36 months]
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Standard photography appearance according to visual analogue scale (VAS)
[Time Frame: 36 months]
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Effects on lipids (fasting triglycerides(TG), total, HDL and LDL cholesterol)
[Time Frame: 36 months]
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Muscle and fat mass measured by abdominal and mid-femoral computerized tomography
[Time Frame: 36 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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