Desmopressin Response in the Young (DRY)

May 18, 2011 updated by: Ferring Pharmaceuticals

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • The Male Health Centres
      • Cambridge, Ontario, Canada, N3C 1Z3
        • Cambridge Family Medical Centre
      • London, Ontario, Canada
        • Private Clinic
      • Markham, Ontario, Canada, L6B 1A1
        • Quest Clinical Trials Inc.
      • North Bay, Ontario, Canada, P1B 4Z2
        • Private Clinic
      • Oakville, Ontario, Canada, L6H 3P1
        • The Male Health Centres
      • Thornhill, Ontario, Canada, L3T 4X1
        • Markham Place Med Centre
      • Whitby, Ontario, Canada, L1N 8M7
        • The Kids Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo
Drug: placebo
placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
Active Comparator: 1
desmopressin
Drug: desmopressin
desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
Other Names:
  • DDAVP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14 days of screening plus 54 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
14 days of screening plus 54 days of treatment
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
14 days of screening plus 54 days of treatment
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
14 days of screening plus 54 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE992026, CLN 10.3.26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Nocturnal Enuresis

Clinical Trials on desmopressin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe