Global Growth Hormone Study in Adults With Prader-Willi Syndrome
NCT04484051
ABOUT THIS STUDY
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- The patient is diagnosed with Prader-Willi syndrome (genetically confirmed)
- The patient is 30 years or older
- In case of previous GH treatment (for example in trial setting), GH should be stopped at least three years before starting the study
- The patient is treated by a dietitian (caloric restriction) for at least three months
- Non cooperative behaviour
- Pregnancy
- Known malignancies
- Poorly controlled diabetes (HbA1c > 64 mmol/mol (8%))
- Untreated obstructive sleep apnea (apnea-hypopnea index > 5)
- Body mass index above 40 kg/m2
- Upper-airway obstruction of any cause
- Change in testosterone or estrogen replacement therapy in the last three months prior
to study
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Descriptive Information | |||||||||||||
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Brief Title ICMJE | Global Growth Hormone Study in Adults With Prader-Willi Syndrome | ||||||||||||
Official Title ICMJE | Global Growth Hormone Study in Adults With Prader-Willi Syndroom | ||||||||||||
Brief Summary | The overall objective of this study is to measure the effect of growth hormone treatment on physical and psychosocial health in adults of 30 years or older with Prader-Willi syndrome. Patients are randomized to placebo or growth hormone treatment during the first year. They will switch treatment during the second year, so that each participant receives one year of growth hormone treatment and one year of placebo (cross-over study). We hypothesize that growth hormone treatment will improve the physical and psychosocial health. | ||||||||||||
Detailed Description | OBJECTIVES: The overall objective is to measure the effect of growth hormone treatment (GHt) on physical and psychosocial health in adults of 30 years or older with Prader-Willi syndrome (PWS). The primary objective is to measure the effect of GHt on lean body mass as measured by Dual Energy X-ray Absorptiometry scan in adults of 30 years or older with PWS. The secondary objective is to measure the effect of GHt on total fat mass, bone density, physical health cardiovascular fitness, laboratory measurements, muscle strength, endurance, and psychosocial functioning in adults of 30 years or older with PWS. Also the occurrence of side-effects will be assessed. STUDY DESIGN: Randomized, double-blinded, placebo controlled crossover trial for two years with a washout period of 3 months. STUDY POPULATION: 50 adults with PWS of 30 years or older who have not been treated with GH during the past three years. INTERVENTION: subcutaneous injections of growth hormone (Genotropin, 5.0 mg/mL) in a dosage of 0.6 - 0.8 mg/day. The comparator is placebo. | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||||||||
Condition ICMJE | Prader-Willi Syndrome | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||||||
Estimated Enrollment ICMJE | 50 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date ICMJE | January 1, 2024 | ||||||||||||
Estimated Primary Completion Date | January 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Netherlands | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04484051 | ||||||||||||
Other Study ID Numbers ICMJE | GGAP | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | dr. Laura C. G. de Graaff-Herder, Erasmus Medical Center | ||||||||||||
Study Sponsor ICMJE | Erasmus Medical Center | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Erasmus Medical Center | ||||||||||||
Verification Date | July 2020 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |