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