Desmopressin Response in the Young
Information source: Ferring Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Nocturnal Enuresis
Intervention: desmopressin (Drug); placebo (Drug)
Phase: Phase 3
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
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.
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.
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
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.
- Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic
- A minimum of 3 wet nights per week in the 2-week screening period without treatment.
- 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.
Locations and Contacts
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