At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
Desmopressin +1 moredrug
Likely dose
Not stated in 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 Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males
In Brief
A Phase 3 clinical trial evaluating Desmopressin and Placebo for Nocturia. Completed, enrolled 395 participants across 56 sites in 2 countries.
Detailed Summary
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNocturia
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartFeb 2011
Primary CompletionJan 2012
TodayJul 2026
First PostedDec 17, 2010
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.5 years ago
Interventions
Desmopressindrug
Placebodrug