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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 February 2015 |
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Main ID: |
NCT00444964 |
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Date of registration:
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06/03/2007 |
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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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Growth Hormone Use in Adults With Prader-Willi Syndrome
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Scientific title:
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Growth Hormone Use 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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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00444964 |
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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: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Merlin G Butler, MD |
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Address:
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Telephone:
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816-234-3290 |
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Email:
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mgbutler@cmh.edu |
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Affiliation:
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Name:
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Merlin G Butler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Children's Mercy Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 16 to 60 years old
- Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing
(e.g., mPCR)
- Low IGF-1 level (e.g.,=25%) at baseline
- Ability to provide informed consent or availability of a suitable legally authorized
representative
Exclusion Criteria:
- Pregnancy
- Previous treatment with growth hormone
- Uncontrolled endocrine disease, (i.e. diabetes or thyroid)
- History of severe scoliosis
- Heart disease
- Uncontrolled high blood pressure or history of stroke
- Morbid obesity (using PWS growth charts)
- Severe sleep apnea or known breathing difficulties/obstruction (as per history or
diagnostic testing results
Age minimum:
16 Years
Age maximum:
60 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: Nutropin AQ
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Primary Outcome(s)
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Improvement of indicators or risk factors for co-morbid diseases [diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function] in participants.
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Increased energy expenditure as determined by whole-room calorimeter measures (8 hour energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors and strength measures
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Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants.
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Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants.
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Increased IGF-1 as a function of human growth hormone dosage compared with baseline
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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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