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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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16 December 2017 |
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Main ID: |
NCT01038570 |
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Date of registration:
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16/11/2009 |
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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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Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus Placebo
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Scientific title:
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Evaluation of the Effect of the Oxytocin Administered in Nasal Pulverizing on the Social Skills, the Stress, the Anxiety and the Eating Habits at Grown-up Patients Presenting a Syndrome of Prader-Willi: Pilot Study |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01038570 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Maïthé TAUBER, 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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Centre de référence du syndrome de Prader-Willi - Equipe d'Endocrinologie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- PWS genetically confirmed,
- Age 18-year-old superior,
- Negative pregnancy test.
Exclusion Criteria:
- Severe psychiatric troubles
- Problem administration staff,
- Saving of justice,
- Abnormalities of the heart rhythm,
- Hepatic or renal insufficiency,
- Pregnancy,
- Oxytocin hypersensibility,
- Treatment causing rhythm disorders.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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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: Syntocinon®/- Spray
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Drug: Physiological serum (Sodium chloride)
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Primary Outcome(s)
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Result scores at Psychological tests : "Reading the mind in the eyes" (RMET), Tests for evaluation of the "theory of mind" : Sally and Ann, Cartoons,"L'esprit des autres", "Social Attribution Task" (SAT).
[Time Frame: fourth day]
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Secondary Outcome(s)
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Result scores at daily stress, anxiety and eating behavior tests
[Time Frame: Five days (first day to fifth day)]
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Secondary ID(s)
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09 071 03
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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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