At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 89 enrolled
Drug / intervention
Desmopressin +1 moredrug
Likely dose
Desmopressin 120 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
In Brief
A Phase 3 clinical trial evaluating Desmopressin and Placebo for Nocturnal Enuresis. Completed, enrolled 89 participants across 15 sites.
Detailed Summary
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNocturnal Enuresis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedMar 2010
Primary CompletionSep 2010
TodayJul 2026
First PostedMar 2, 2010
Enrollment StartJan 1, 2010
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.3 years ago
Interventions
Desmopressindrug
Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.
Placebodrug
Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.