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

Ferring

Status and phase

Completed

Phase 4

Conditions

Nocturnal Enuresis

Treatments

Drug: Primary nocturnal enuresis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00245479

FE992026 CS002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

802 patients

Sex

All

Ages

5 to 15 years old

Volunteers

Accepts Healthy Volunteers

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