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

Nocturnal Enuresis Clinical Trial

— DRIP  

Official title:

An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245479
• Other study ID #: FE992026 CS002
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 18, 2011
• Start date: April 2002
• Est. completion date: November 2006

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: November 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis

Intervention

Drug:
• Primary nocturnal enuresis
Desmopressin

Locations

Country	Name	City	State
France	Foundation Hospital Saint Joseph, 185, rue Raymond Losserand	Paris Cedex 14

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.
Secondary	To evaluate the proportion of patients achieving dryness.
Secondary	To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.