A Study of ASP8302 in Participants With Underactive Bladder

Phase 2 Completed 135 enrolled Astellas Pharma Europe B.V.

RandomizedParallel-groupDouble-blindTreatment

Summary

The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in participants with UAB, to investigate the pharmacokinetics of ASP8302 in participants with UAB and to support the development of the UAB - Patient Reported Outcome (PRO).

Timeline

Start: 2018-11-20
Primary completion: 2020-04-28
Completion: 2020-04-28

Outcome

Missed primary endpoint

paper the difference between groups was -5.0 ml (p = 0.960). PMID 35419807 ↗

paper it did not show efficacy in the primary endpoint. PMID 35419807 ↗

Publications

van Till JWO, Arita E, Kuroishi K, Croy R, Oelke M, van Koeveringe GA, Chapple CR, Yamaguchi O, Abrams P. Muscarinic-3-receptor positive allosteric modulator ASP8302 in patients with underactive bladder. A randomized controlled trial. Neurourol Urodyn. 2022 Jun;41(5):1139-1148. doi: 10.1002/nau.24931. Epub 2022 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP8302	Small molecule	100 mg	Oral