A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.

To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.

To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

• 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