Desmopressin Response in the Young (DRY)

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00230594
First received: September 28, 2005
Last updated: May 18, 2011
Last verified: May 2011

September 28, 2005
May 18, 2011
July 2004
January 2006   (final data collection date for primary outcome 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. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00230594 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Desmopressin Response in the Young
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Nocturnal Enuresis
  • Drug: desmopressin
    desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
    Other Name: DDAVP
  • Drug: placebo
    placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
  • Active Comparator: 1
    desmopressin
    Intervention: Drug: desmopressin
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
February 2006
January 2006   (final data collection date for primary outcome measure)

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.
Both
5 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00230594
FE992026, CLN 10.3.26
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP