At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 302 enrolled
Drug / intervention
FE 201836 +3 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 Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults
In Brief
A Phase 2 clinical trial evaluating FE 201836, Desmopressin, and 2 other interventions for Nocturia. Completed, enrolled 302 participants across 72 sites in 7 countries.
Detailed Summary
The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNocturia
CountriesBelgium, Canada, Czechia, Germany, Hungary, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJul 2017
Primary CompletionOct 2019
TodayJul 2026
First PostedJun 28, 2017
Enrollment StartJul 27, 2017
Primary CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.0 years ago
Interventions
FE 201836drug
Oral solution for daily intake
Desmopressindrug
Desmopressin Orally Disintegrating Tablet (ODT)
Placebo oral solutiondrug
Manufactured to mimic experimental drug
Placebo ODTdrug
Manufactured to mimic experimental drug