EUCTR2021-000094-91-FRActive, not recruitingPhase 1
EFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA RELATED TO OROPHARYNGO-OESOPHAGEAL DYSMOTILITY TRANSIT IN CHILDREN AND ADOLESCENTS WITH PRADER-WILLI SYNDROME: A PHASE 3 STUDY (DYSMOT) - DYSMOT
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Toulouse University Hospital
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Male or female patients aged between 2 and 17,5 years.
- •2.Genetically confirmed diagnosis of PWS.
- •3.Parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. A history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex;
- •2.Intolerance of intranasal administrations (including when due to a major behavioural problem);
- •3.Hyponatremia (clinically relevant at the discretion of the investigator);
- •4.Hypokalaemia (clinically relevant at the discretion of the investigator);
- •5.Prolongation of the QT interval and/or family history of prolongation of the QT interval;
- •6.Concomitant treatment prolonging the QT interval;
- •7.History of abnormal electrocardiogram (ECG) (validated by a cardiologist);
- •8.Pregnant girls; (for girls aged 14 years of above who do not have contraception and are sexually active, a negative pregnancy test will be required)
- •9.Patient with clinical signs in the context of contact with SARs-COV2 infected person
- •10.Patient included in another study protocol on a medicinal product within the last 6 months
- •11.Administrative problems:
Investigators
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