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Desmopressin Response in the Young (DRY)

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00230594
First received: September 28, 2005
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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 3

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: Yes ]

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
Active Comparator: 1
desmopressin
Drug: desmopressin
desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
Other Name: DDAVP
Placebo Comparator: 2
placebo
Drug: placebo
placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime

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 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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230594

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
The Male Health Centres
Barrie, Ontario, Canada, L4M 7G1
Cambridge Family Medical Centre
Cambridge, Ontario, Canada, N3C 1Z3
Private Clinic
London, Ontario, Canada
Quest Clinical Trials Inc.
Markham, Ontario, Canada, L6B 1A1
Private Clinic
North Bay, Ontario, Canada, P1B 4Z2
The Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
Markham Place Med Centre
Thornhill, Ontario, Canada, L3T 4X1
The Kids Clinic
Whitby, Ontario, Canada, L1N 8M7
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00230594     History of Changes
Other Study ID Numbers: FE992026, CLN 10.3.26
Study First Received: September 28, 2005
Last Updated: May 18, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Urination Disorders
Urologic Diseases
Deamino Arginine Vasopressin
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014