A 6-week open label cross-over study with 2 different daily doses of Minirin® oral lyophilisate (120 µg and 240 µg) and 2 different daily doses of Minirin® tablet (0.2 mg and 2 x 0.2 mg) in children and adolescents with primary nocturnal enuresis (PNE) - PALAT

Ferring Pharmaceuticals A/S0 个研究点目标入组 200 人开始时间: 2004年12月1日最近更新: 2012年5月29日

适应症

试验速览

暂无简介。

•1. Male or female, 5 to 15 years of age (inclusive) (or according to the minimum age as specified in the marketing authorisation in each country)
•2. Primary monosymptomatic nocturnal enuretic subjects
•3. Stabilised (at least 2 weeks) on 0.2 mg or 2 x 0.2 mg desmopressin at the screening visit
•4. Female subjects must be pre-menarchial or sexually inactive. Otherwise, contraception must be used and a negative pregnancy test must be obtained
•5. Parents of the child must voluntarily sign a written informed consent agreement, after explanation of the nature and objectives of the study and prior to any study specific procedure and prior to treatment. It must be thoroughly explained that the consent can be withdrawn at any time without prejudice. The IEC must approve the informed consent agreement
•6. Where appropriate, participants should assent to enrol in the study (age of assent to be determined by IECs or be consistent with local legal requirements)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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. Presence or history of organic urological disease, diurnal urinary incontinence, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation (other cause)
•2. Ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity (safety)
•3. Use of any experimental drug or device during 30 days before the screening visit (methodological)
•4. Use of non-pharmacological therapy (e.g. bed alarms) during 60 days before the screening visit (methodological)
•5. Is hypersensitive towards any component of the investigational product (safety)
•6. The subject and/or the subject's parents have mental incapacity or language barriers precluding adequate understanding or co-operation (methodological)

发起方