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

Phase 4

Completed

• Conditions: Nocturnal Enuresis
• Interventions: Drug: Primary nocturnal enuresis

• Registration Number: NCT00245479
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Study Completion: 2006-11
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 802

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Primary nocturnal enuresis	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Foundation Hospital Saint Joseph, 185, rue Raymond Losserand; 🇫🇷 Paris Cedex 14, France