Study of ONO-8577 in Patients With Overactive Bladder

Phase 2

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: ONO-8577; Drug: Placebo; Drug: solifenacin succinate + mirabegron

• Registration Number: NCT03106623
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-04-03
• Study Start: 2017-04-07
• Study First Posted: 2017-04-10
• Primary Completion: 2017-08-29
• Study Completion: 2017-09-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-8577 Arm	ONO-8577	Oral administration of ONO-8577 once a daily for 4 weeks
Placebo Arm	Placebo	Oral administration of Placebo once a daily for 4 weeks
Active Comparator Arm	solifenacin succinate + mirabegron	Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)	Baseline and Week 2
Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)	Baseline and Week 4
Efficacy (Patient Global Impression at Week 4)	Week 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition)	Baseline, Week 2 and 4
Pharmacokinetics (plasma concentration at one point on each visit)	Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4	Week 2 and 4
Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )	Baseline, Week 2 and 4
Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)	Up to Week 4
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours)	Baseline, Week 2 and 4
Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)	Week 2 and 4

Trial Locations

Locations (30)

Gunma Clinical Site 02; 🇯🇵 Maebashi, Gunma, Japan

Hyogo Clinical Site 02; 🇯🇵 Akashi, Hyogo, Japan

Gunma Clinical Site 01; 🇯🇵 Takasaki, Gunma, Japan

Hyogo Clinical Site 01; 🇯🇵 Kobe, Hyogo, Japan

Hyogo Clinical Site 03; 🇯🇵 Kobe, Hyogo, Japan

Kanagawa Clinical Site 01; 🇯🇵 Isehara, Kanagawa, Japan

Kanagawa Clinical Site 02; 🇯🇵 Kamakura, Kanagawa, Japan

Osaka Clinical Site 04; 🇯🇵 Ibaraki, Osaka, Japan

Saitama Clinical Site 01; 🇯🇵 Kumagaya, Saitama, Japan

Osaka Clinical Site 01; 🇯🇵 Osaka, Takatsuki-shi, Japan

Tokyo Clinical Site 10; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Tokyo Clinical Site 01; 🇯🇵 Edogawa-ku, Tokyo, Japan

Tokyo Clinical Site 03; 🇯🇵 Ota-ku, Tokyo, Japan

Tokyo Clinical Site 09; 🇯🇵 Nakano-ku, Tokyo, Japan

Tokyo Clinical Site 08; 🇯🇵 Setagaya-ku, Tokyo, Japan

Tokyo Clinical Site 04; 🇯🇵 Shinagawa-ku, Tokyo, Japan

Tokyo Clinical Site 05; 🇯🇵 Shinagawa-ku, Tokyo, Japan

Kyoto Clinical Site 01; 🇯🇵 Kyoto, Japan

Kanagawa Clinical Site 04; 🇯🇵 Yokohama, Kanagawa, Japan

Osaka Clinical Site 05; 🇯🇵 Suita, Osaka, Japan

Hyogo Clinical Site 04; 🇯🇵 Takarazuka, Hyogo, Japan

Osaka Clinical Site 03; 🇯🇵 Higashiosaka, Osaka, Japan

Osaka Clinical Site 06; 🇯🇵 Toyonaka, Osaka, Japan

Osaka Clinical Site 07; 🇯🇵 Toyonaka, Osaka, Japan

Osaka Clinical Site 02; 🇯🇵 Osaka-shi, Osaka, Japan

Kanagawa Clinical Site 03; 🇯🇵 Sagamihara, Kanagawa, Japan

Tokyo Clinical Site 11; 🇯🇵 Setagaya-ku, Tokyo, Japan

Tokyo Clinical Site 06; 🇯🇵 Itabashi-ku, Tokyo, Japan

Tokyo Clinical Site 02; 🇯🇵 Suginami-ku, Tokyo, Japan

Tokyo Clinical Site 07; 🇯🇵 Nerima-ku, Tokyo, Japan