Desmopressin Response in the Young

Condition(s) targeted: Primary Nocturnal Enuresis

Intervention: desmopressin (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Richard W Casey, MD, Principal Investigator, Affiliation: The Male Health Centres

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.

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).

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: 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.

Secondary outcome:

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.

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.

To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested.

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.

Minimum age: 5 Years. Maximum age: 16 Years. Gender(s): Both.

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.

IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada

The Male Health Centres, Oakville, Ontario L6H 3P1, Canada

Private Clinic, London, Ontario, Canada

Quest Clinical Trials Inc., Markham, Ontario L6B 1A1, Canada

Private Clinic, North Bay, Ontario P1B 4Z2, Canada

Markham Place Med Centre, Thornhill, Ontario L3T 4X1, Canada

The Kids Clinic, Whitby, Ontario L1N 8M7, Canada

Cambridge Family Medical Centre, Cambridge, Ontario N3C 1Z3, Canada

The Male Health Centres, Barrie, Ontario L4M 7G1, Canada

Starting date: July 2004
Ending date: February 2006
Last updated: May 6, 2008