Desmopressin Response in the Young

Last updated: May 18, 2011
Sponsor: Ferring Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Urinary Incontinence

Nocturia

Enuresis

Treatment

N/A

Clinical Study ID

NCT00230594
FE992026, CLN 10.3.26
  • Ages 5-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children and adolescents (age 5-16 years) with diagnosed primary monosymptomaticnocturnal enuresis.

  • A minimum of 3 wet nights per week in the 2-week screening period without treatment.

Exclusion

Exclusion Criteria:

  • Presence or a history of organic urological disease, diurnal urinary incontinence,polydipsia, diabetes insipidus, ongoing urinary tract infection, clinicallysignificant 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 urinaryconcentration, or medical treatment for hyperactivity.

  • Usage of any experimental drug or device during 30 days before study entry.

Study Design

Total Participants: 132
Study Start date:
July 01, 2004
Estimated Completion Date:
February 28, 2006

Study 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.

Connect with a study center

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • The Male Health Centres

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Cambridge Family Medical Centre

    Cambridge, Ontario N3C 1Z3
    Canada

    Site Not Available

  • Private Clinic

    London, Ontario
    Canada

    Site Not Available

  • Quest Clinical Trials Inc.

    Markham, Ontario L6B 1A1
    Canada

    Site Not Available

  • Private Clinic

    North Bay, Ontario P1B 4Z2
    Canada

    Site Not Available

  • The Male Health Centres

    Oakville, Ontario L6H 3P1
    Canada

    Site Not Available

  • Markham Place Med Centre

    Thornhill, Ontario L3T 4X1
    Canada

    Site Not Available

  • The Kids Clinic

    Whitby, Ontario L1N 8M7
    Canada

    Site Not Available

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