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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.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01038570
Date of registration: 16/11/2009
Prospective Registration: Yes
Primary sponsor: University Hospital, Toulouse
Public title: Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus Placebo
Scientific title: 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
Date of first enrolment: June 2009
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01038570
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
France
Contacts
Name:     Maïthé TAUBER, MD
Address: 
Telephone:
Email:
Affiliation:  Centre de référence du syndrome de Prader-Willi - Equipe d'Endocrinologie
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Prader Willi Syndrome
Intervention(s)
Drug: Physiological serum (Sodium chloride)
Drug: Syntocinon®/- Spray
Primary Outcome(s)
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]
Secondary Outcome(s)
Result scores at daily stress, anxiety and eating behavior tests [Time Frame: Five days (first day to fifth day)]
Secondary ID(s)
09 071 03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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