Primary Nocturnal Enuresis Clinical Trial
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00209261 -
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
|
Phase 4 |