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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00230594 |
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.
Condition | Intervention | Phase |
---|---|---|
Primary Nocturnal Enuresis |
Drug: desmopressin Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Desmopressin Response in the Young: A Double-Blind, Randomised, Placebo-Controlled, Dose-Titration Study With Three Different Doses (120 Mcg, 240 Mcg and 360 Mcg) of Desmopressin Administered as a New Melt Tablet in Children and Adolescents With Primary Nocturnal Enuresis (PNE). |
Enrollment: | 132 |
Study Start Date: | July 2004 |
Study Completion Date: | February 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
desmopressin
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Drug: desmopressin
desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
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2: Placebo Comparator
placebo
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Drug: placebo
placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
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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 deficiency of antidiuretic hormone arginine vasopressin (AVP) which has been supported by the finding that some enuretic children lack a nocturnal increase in endogenous AVP secretion. Desmopressin, a synthetic, structural analogue of AVP, selective for V2-receptors and with a longer half life than the natural hormone, has been found to be especially beneficial in PNE subjects with nocturnal polyuria and normal functional bladder capacity.
A melt tablet formulation offers benefits compared to regular tablets and nasal spray. Regular tablets are more difficult to swallow for some patients and require fluid intake for swallowing. Nasal spray absorption may be altered by seasonal allergies, upper respiratory infections or improper administration.
Ages Eligible for Study: | 5 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Nova Scotia | |
IWK Health Centre | |
Halifax, Nova Scotia, Canada, B3K 6R8 | |
Canada, Ontario | |
The Male Health Centres | |
Oakville, Ontario, Canada, L6H 3P1 | |
Private Clinic | |
London, Ontario, Canada | |
Quest Clinical Trials Inc. | |
Markham, Ontario, Canada, L6B 1A1 | |
The Male Health Centres | |
Barrie, Ontario, Canada, L4M 7G1 | |
Markham Place Med Centre | |
Thornhill, Ontario, Canada, L3T 4X1 | |
The Kids Clinic | |
Whitby, Ontario, Canada, L1N 8M7 | |
Cambridge Family Medical Centre | |
Cambridge, Ontario, Canada, N3C 1Z3 | |
Private Clinic | |
North Bay, Ontario, Canada, P1B 4Z2 |
Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
Responsible Party: | Ferring Pharmaceuticals ( Hjort, Director ) |
Study ID Numbers: | FE992026, CLN 10.3.26 |
Study First Received: | September 28, 2005 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00230594 History of Changes |
Health Authority: | Canada: Health Canada |
Arginine Vasopressin Urologic Diseases Nocturnal Enuresis Mental Disorders Urination Disorders Enuresis |
Deamino Arginine Vasopressin Mental Disorders Diagnosed in Childhood Vasopressins Cardiovascular Agents Hemostatics Behavioral Symptoms |
Coagulants Enuresis Urination Disorders Elimination Disorders Hematologic Agents Physiological Effects of Drugs Cardiovascular Agents Hemostatics Pharmacologic Actions |
Behavioral Symptoms Nocturnal Enuresis Urologic Diseases Mental Disorders Natriuretic Agents Therapeutic Uses Deamino Arginine Vasopressin Mental Disorders Diagnosed in Childhood Antidiuretic Agents |