Clinical trial NCT00230594: Desmopressin Response in the Young
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Nocturnal Enuresis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 132
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 14 days of screening plus 54 days of treatment
Secondary outcomes:
measure: 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.
timeFrame: 14 days of screening plus 54 days of treatment
measure: 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.
timeFrame: 14 days of screening plus 54 days of treatment
measure: To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested.
timeFrame: 14 days of screening plus 54 days of treatment
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: The Male Health Centres
state: Ontario
city: Cambridge
country: Canada
facility: Cambridge Family Medical Centre
state: Ontario
city: London
country: Canada
facility: Private Clinic
state: Ontario
city: Markham
country: Canada
facility: Quest Clinical Trials Inc.
state: Ontario
city: North Bay
country: Canada
facility: Private Clinic
state: Ontario
city: Oakville
country: Canada
facility: The Male Health Centres
state: Ontario
city: Thornhill
country: Canada
facility: Markham Place Med Centre
state: Ontario
city: Whitby
country: Canada
facility: The Kids Clinic
state: Ontario
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.