Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects

Summary

The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

Timeline

Start

2016-09

Primary completion

2017-09-27

Completion

2017-09-27

Outcome

Missed primary endpoint

paper The reduction in the number of nocturnal voids (-1.11) was not significantly different compared with placebo (P = .0975). PMID 31397969 ↗

Publications

• Results Yamaguchi O, Juul KV, Falahati A, Yoshimura T, Imura F, Kitamura M. Efficacy and safety of 25 and 50 mug desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: Results from two phase 3 studies of a multicenter randomized double-blind placebo-controlled parallel-group development program. Low Urin Tract Symptoms. 2020 Jan;12(1):8-19. doi: 10.1111/luts.12276. Epub 2019 Aug 9.

Drugs

Indications

No indication recorded.