NCT03201419

A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	FE 201836	Oral solution for daily intake
DRUG	Desmopressin	Desmopressin Orally Disintegrating Tablet (ODT)
DRUG	Placebo oral solution	Manufactured to mimic experimental drug
DRUG	Placebo ODT	Manufactured to mimic experimental drug

Timeline

• Start date: 2017-07-27
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2017-06-28
• Last updated: 2022-03-02
• Results posted: 2020-12-23

Locations

72 sites across 7 countries: United States, Belgium, Canada, Czechia, Germany, Hungary, Poland

Regulatory

• FDA-regulated drug study