At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 799 enrolled
Drug / intervention
desmopressin acetate +1 moredrug
Likely dose
desmopressin acetate 100 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 Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
In Brief
A Phase 3 clinical trial evaluating desmopressin acetate and Placebo for Nocturia. Completed, enrolled 799 participants across 80 sites in 2 countries.
Detailed Summary
The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNocturia
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionFeb 2008
TodayJul 2026
First PostedMay 23, 2007
Enrollment StartMay 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.1 years ago
Interventions
desmopressin acetatedrug
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Placebodrug
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.