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

NCT03201419 ↗

Phase 2 Completed 302 enrolled Ferring Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start: 2017-07-27
Primary completion: 2019-10-31
Completion: 2019-10-31

Outcome

Met primary endpoint

registry analysis (superiority test); FE 201836 500 ug (Randomized Treatment Period) vs Placebo (Randomized Treatment Period); Mean Difference -0.30 (95% CI -0.54 to -0.07) NCT03201419 ↗

Publications

Background Hudgens S, Howerter A, Polek E, Andersson FL. Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting. Qual Life Res. 2022 Jun;31(6):1837-1848. doi: 10.1007/s11136-021-03060-4. Epub 2021 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desmopressin	Peptide	25 ug	Oral
Subject	Desmopressin	Peptide	50 ug	Oral
Subject	FE 201836	Unknown	50 ug	Oral
Subject	FE 201836	Unknown	100 ug	Oral
Subject	FE 201836	Unknown	150 ug	Oral
Subject	FE 201836	Unknown	250 ug	Oral
Subject	FE 201836	Unknown	350 ug	Oral
Subject	FE 201836	Unknown	500 ug	Oral

Indications

No indication recorded.