Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.

Phase 2 Completed 195 enrolled Taiho Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.

Timeline

Start: 2017-09-09
Primary completion: 2019-11-01
Completion: 2020-03-27

Outcome

Mixed primary results

registry analysis (superiority test); TAC-302 vs Placebo; p = 0.015; Mean Difference (Final Values) 11.378 (95% CI 2.345 to 20.411); t-test, 2 sided NCT03175029 ↗

registry analysis (superiority test); TAC-302 vs Placebo; p = 0.157; Mean Difference (Final Values) 5.678 (95% CI -2.375 to 13.731); t-test, 2 sided NCT03175029 ↗

Publications

Yoshida M, Gotoh M, Yokoyama O, Kakizaki H, Yamanishi T, Yamaguchi O. Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study. World J Urol. 2022 Nov;40(11):2799-2805. doi: 10.1007/s00345-022-04163-4. Epub 2022 Oct 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TAC-302	Unknown	200 mg	Oral