Desmopressin Response in the Young

Primary Nocturnal Enuresis Clinical Trial

— DRY  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230594
• Other study ID #: FE992026, CLN 10.3.26
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2005
• Last updated: May 18, 2011
• Start date: July 2004
• Est. completion date: February 2006

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Primary Nocturnal Enuresis

Intervention

Drug:
• desmopressin
desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
• placebo
placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime

Locations

Country	Name	City	State
Canada	The Male Health Centres	Barrie	Ontario
Canada	Cambridge Family Medical Centre	Cambridge	Ontario
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Private Clinic	London	Ontario
Canada	Quest Clinical Trials Inc.	Markham	Ontario
Canada	Private Clinic	North Bay	Ontario
Canada	The Male Health Centres	Oakville	Ontario
Canada	Markham Place Med Centre	Thornhill	Ontario
Canada	The Kids Clinic	Whitby	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of reducing the number of wet nights in children and adolescents with primary nocturnal enuresis.		14 days of screening plus 54 days of treatment	No
Secondary	To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of percentage baseline reduction in the number of wet nights.		14 days of screening plus 54 days of treatment	No
Secondary	To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of the proportion of full, partial and non-responders.		14 days of screening plus 54 days of treatment	No
Secondary	To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested.		14 days of screening plus 54 days of treatment	Yes