Clinical Trial: A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
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 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.
Sponsor: Ferring Pharmaceuticals
Current Primary Outcome: To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
- • 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.
Information By: Ferring Pharmaceuticals
Dates:
Date Received: September 13, 2005
Date Started: April 2002
Date Completion:
Last Updated: May 18, 2011
Last Verified: May 2011
