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

Toulouse University Hospital0 个研究点目标入组 36 人开始时间: 2021年4月1日最近更新: 2022年2月1日

适应症

试验速览

暂无简介。

•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

•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:

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