Clinical Trial: Desmopressin Response in the Young
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
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.
Sponsor: Ferring Pharmaceuticals
Current 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. [ Time Frame: 14 days of screening plus 54 days of treatment ]
Original 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.
Current 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. [ Time Frame: 14 days of screening plus 54 days of treatment ]
- 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 ]
- 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 ]
Original Secondary Outcome:
Information By: Ferring Pharmaceuticals
Dates:
Date Received: September 28, 2005
Date Started: July 2004
Date Completion:
Last Updated: May 18, 2011
Last Verified: May 2011
