Primary Nocturnal Enuresis MedDRA version: 6.1 Level: low Classification code 10029453
Conditions
Interventions
Product Name: Minirin oral lyophilisate (Minirin Plus 120 µg)
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: Desmopressin (approved INN)
CAS Number: 16679-58-6
Concentration unit: µg micr
Sponsors
Ferring Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 5 to 15 years of age (inclusive) (or according to the minimum age as specified in the marketing authorisation of 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 mut 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 procedures 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 It must be thoroughly explained that the consent can be withdrawn at any time without prejudice.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) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of history of organic urological disease, diurnal urinary incontinence, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, encocrinologicyl 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The subjects will be asked a question regarding which treatment (Minirin oral lyophilisate or Minirin tablet) they preferred at the end of 6 weeks treatment.;Secondary Objective: 1. To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data 2. To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. 3. To validate a PNE Quality of Life (QoL) questionnaire. 4. To evaluate safety. 5. To compare compliance with the 2 formulations.;Main Objective: To evaluate the preference of subjects for Minirin oral lyophilisate treatment compared with Minirin tablet treatment after 6 weeks. | — |
Countries
Denmark, Finland, Germany, Sweden, United Kingdom
Outcome results
None listed