Status:
COMPLETED
Desmopressin Response in the Young
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Primary Nocturnal Enuresis
Eligibility:
All Genders
5-16 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether desmopressin administered as a melt tablet is effective in reducing the number of wet nights in children and adolescents who suffer from bedwetting.
Detailed Description
Primary nocturnal enuresis (PNE), or bedwetting, is a common childhood urological disease. Factors contributing to nocturnal enuresis include nocturnal polyuria due to, at least in part, a relative de...
Eligibility Criteria
Inclusion
- Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis.
- A minimum of 3 wet nights per week in the 2-week screening period without treatment.
Exclusion
- Presence or a history of organic urological disease, diurnal urinary incontinence, polydipsia, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation.
- Ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity.
- Usage of any experimental drug or device during 30 days before study entry.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00230594
Start Date
July 1 2004
End Date
February 1 2006
Last Update
May 19 2011
Active Locations (9)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
2
The Male Health Centres
Barrie, Ontario, Canada, L4M 7G1
3
Cambridge Family Medical Centre
Cambridge, Ontario, Canada, N3C 1Z3
4
Private Clinic
London, Ontario, Canada