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Study of ONO-8577 in Patients With Overactive Bladder

NCT ID: NCT03106623

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2017-09-26

Brief Summary

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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

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Urinary Bladder Overactive Overactive Bladder Urgency Incontinence +1 more
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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ONO-8577 Arm

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

Group Type EXPERIMENTAL

ONO-8577

Intervention Type DRUG

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

Active Comparator Arm

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

Group Type ACTIVE_COMPARATOR

solifenacin succinate + mirabegron

Intervention Type DRUG

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

Placebo Arm

Oral administration of Placebo once a daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration of Placebo once a daily for 4 weeks

Interventions

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ONO-8577

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

Intervention Type DRUG

solifenacin succinate + mirabegron

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

Intervention Type DRUG

Placebo

Oral administration of Placebo once a daily for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hitoshi Kajitani

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Gunma Clinical Site 02

Maebashi, Gunma, Japan

Site Status

Gunma Clinical Site 01

Takasaki, Gunma, Japan

Site Status

Hyogo Clinical Site 02

Akashi, Hyōgo, Japan

Site Status

Hyogo Clinical Site 01

Kobe, Hyōgo, Japan

Site Status

Hyogo Clinical Site 03

Kobe, Hyōgo, Japan

Site Status

Hyogo Clinical Site 04

Takarazuka, Hyōgo, Japan

Site Status

Kanagawa Clinical Site 01

Isehara, Kanagawa, Japan

Site Status

Kanagawa Clinical Site 02

Kamakura, Kanagawa, Japan

Site Status

Kanagawa Clinical Site 03

Sagamihara, Kanagawa, Japan

Site Status

Kanagawa Clinical Site 04

Yokohama, Kanagawa, Japan

Site Status

Osaka Clinical Site 03

Higashiosaka, Osaka, Japan

Site Status

Osaka Clinical Site 04

Ibaraki, Osaka, Japan

Site Status

Osaka Clinical Site 02

Osaka, Osaka, Japan

Site Status

Osaka Clinical Site 05

Suita, Osaka, Japan

Site Status

Osaka Clinical Site 06

Toyonaka, Osaka, Japan

Site Status

Osaka Clinical Site 07

Toyonaka, Osaka, Japan

Site Status

Saitama Clinical Site 01

Kumagaya, Saitama, Japan

Site Status

Osaka Clinical Site 01

Osaka, Takatsuki-shi, Japan

Site Status

Tokyo Clinical Site 10

Bunkyo-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 01

Edogawa-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 06

Itabashi-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 09

Nakano-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 07

Nerima-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 03

Ōta-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 08

Setagaya-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 11

Setagaya-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 04

Shinagawa-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 05

Shinagawa-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 02

Suginami-ku, Tokyo, Japan

Site Status

Kyoto Clinical Site 01

Kyoto, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-8577-02

Identifier Type: -

Identifier Source: org_study_id

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