Overview

A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks. To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data. To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ferring Pharmaceuticals
Treatments:
Deamino Arginine Vasopressin
Criteria
Inclusion Criteria:

- Children suffering from primary nocturnal enuresis with no organic pathology.

- Children of either sex, not below 5 and not above 15 years of age (not below 6 years
in The Netherlands and France).

- Children with a minimum of 6 wet nights in 2 weeks.

Exclusion Criteria:

- Children who have previously been treated with desmopressin or other medications for
nocturnal enuresis or enuresis alarms.

- Children receiving substances that are known or suspected to potentiate antidiuretic
hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.

- Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine
vasopressin) deficiency.

- Proven urinary tract infection within the past month or a documented positive urine
culture at the start of the study