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

Ferring Pharmaceuticals802 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

802

Conditions

Nocturnal Enuresis

Interventions

Primary nocturnal enuresisDRUG

Desmopressin

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Foundation Hospital Saint Joseph, 185, rue Raymond Losserand

Paris, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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