Primary noctural enuresis
Conditions
Interventions
Trade Name: MINIRIN
Product Name: MINIRIN
Pharmaceutical Form: Tablet
INN or Proposed INN: desmopressin
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0,2-0,4
Sponsors
FERRING ARZNEIMITTEL Ges.m.b.h. CEE AUSTRIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • children suffering from primary nocturnal enuresis with no known organic pathology • children of either sex, not below 5 and not above 15 years of age • children with a minimum of 4 wet nights in 2 weeks 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
Exclusion criteria
Exclusion criteria: • children who have been previously treated with desmopressin or other medication for nocturnal enuresis • children receiving substances that are known or suspected to potentiate antidiuretic hormone, SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine • diagnosed renal diabetes insipidus or central diabetes insipidus • proven urinary infection within the past 3 months or a documented positive urine culture at the beginning of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall response to desmopressin treatment among enuretic children aged 5-15 years after 3 months of treatment;Secondary Objective: To evaluate the safety profile of oral desmopressin in children with primary noctural enuresis;Primary end point(s): Reduction (%) in number of wet nights after 3 months versus baseline period | — |
Countries
Slovenia
Outcome results
None listed