Study of ONO-8577 in Patients With Overactive Bladder

NCT03106623 | Completed Phase 2

• 1 other identifier: ONO-8577-02
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 30

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

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

  Baseline and Week 4

Secondary Outcomes (14)

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

  Up to Week 4

• Pharmacokinetics (plasma concentration at one point on each visit)

  Week 2 and 4

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

  Baseline and Week 2

• 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

Study Arms (3)

ONO-8577 Arm

EXPERIMENTAL

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

Drug: ONO-8577

Active Comparator Arm

ACTIVE COMPARATOR

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

Drug: solifenacin succinate + mirabegron

Placebo Arm

PLACEBO COMPARATOR

Oral administration of Placebo once a daily for 4 weeks

Drug: Placebo

Interventions

ONO-8577 DRUG

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

ONO-8577 Arm

solifenacin succinate + mirabegron DRUG

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

Active Comparator Arm

Placebo DRUG

Oral administration of Placebo once a daily for 4 weeks

Placebo Arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with symptoms of overactive bladder for ≥6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (30)

Gunma Clinical Site 02

Maebashi, Gunma, Japan

Location

Gunma Clinical Site 01

Takasaki, Gunma, Japan

Location

Hyogo Clinical Site 02

Akashi, Hyōgo, Japan

Location

Hyogo Clinical Site 01

Kobe, Hyōgo, Japan

Location

Hyogo Clinical Site 03

Kobe, Hyōgo, Japan

Location

Hyogo Clinical Site 04

Takarazuka, Hyōgo, Japan

Location

Kanagawa Clinical Site 01

Isehara, Kanagawa, Japan

Location

Kanagawa Clinical Site 02

Kamakura, Kanagawa, Japan

Location

Kanagawa Clinical Site 03

Sagamihara, Kanagawa, Japan

Location

Kanagawa Clinical Site 04

Yokohama, Kanagawa, Japan

Location

Osaka Clinical Site 03

Higashiosaka, Osaka, Japan

Location

Osaka Clinical Site 04

Ibaraki, Osaka, Japan

Location

Osaka Clinical Site 02

Osaka, Osaka, Japan

Location

Osaka Clinical Site 05

Suita, Osaka, Japan

Location

Osaka Clinical Site 06

Toyonaka, Osaka, Japan

Location

Osaka Clinical Site 07

Toyonaka, Osaka, Japan

Location

Saitama Clinical Site 01

Kumagaya, Saitama, Japan

Location

Osaka Clinical Site 01

Osaka, Takatsuki-shi, Japan

Location

Tokyo Clinical Site 10

Bunkyo-ku, Tokyo, Japan

Location

Tokyo Clinical Site 01

Edogawa-ku, Tokyo, Japan

Location

Tokyo Clinical Site 06

Itabashi-ku, Tokyo, Japan

Location

Tokyo Clinical Site 09

Nakano-ku, Tokyo, Japan

Location

Tokyo Clinical Site 07

Nerima-ku, Tokyo, Japan

Location

Tokyo Clinical Site 03

Ōta-ku, Tokyo, Japan

Location

Tokyo Clinical Site 08

Setagaya-ku, Tokyo, Japan

Location

Tokyo Clinical Site 11

Setagaya-ku, Tokyo, Japan

Location

Tokyo Clinical Site 04

Shinagawa-ku, Tokyo, Japan

Location

Tokyo Clinical Site 05

Shinagawa-ku, Tokyo, Japan

Location

Tokyo Clinical Site 02

Suginami-ku, Tokyo, Japan

Location

Kyoto Clinical Site 01

Kyoto, Japan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hitoshi Kajitani

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 10, 2017
• Study Start: April 7, 2017
• Primary Completion: August 29, 2017
• Study Completion: September 26, 2017
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (30)