Status:
COMPLETED
A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Nocturnal Enuresis
Eligibility:
All Genders
5-15 years
Phase:
PHASE4
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 pre...
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 pre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
802 Patients enrolled
Trial Details
Trial ID
NCT00245479
Start Date
April 1 2002
End Date
November 1 2006
Last Update
May 19 2011
Active Locations (1)
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1
Foundation Hospital Saint Joseph, 185, rue Raymond Losserand
Paris, France, 75674