Study of ONO-8577 in Patients With Overactive Bladder

Ono Pharmaceutical Co., Ltd.207 enrolled

Overview

The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to combination of solifenacin succinate and mirabegron or placebo for overactive bladder

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

207

Conditions

Overactive Bladder

Interventions

ONO-8577DRUG

Oral administration of ONO-8577 once a daily for 4 weeks

solifenacin succinate + mirabegronDRUG

Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks

PlaceboDRUG

Oral administration of Placebo once a daily for 4 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with symptoms of overactive bladder for ≥6 months Exclusion Criteria: * Patient with genuine stress incontinence, or with stress-predominant mixed urinary incontinence * Patient who has never experienced urge urinary incontinence during disease duration of overactive bladder

Locations (30)

Gunma Clinical Site 02

Maebashi, Gunma, Japan

Outcomes

Primary Outcomes

Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)

Time frame: Baseline and Week 4

Secondary Outcomes

Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)

Time frame: Up to Week 4

Pharmacokinetics (plasma concentration at one point on each visit)

Time frame: Week 2 and 4

Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)

Time frame: Baseline and Week 2

Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)