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Study of ONO-8577 in Patients With Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ONO-8577
solifenacin succinate + mirabegron
Placebo
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gunma Clinical Site 02
  • Gunma Clinical Site 01
  • Hyogo Clinical Site 02
  • Hyogo Clinical Site 01
  • Hyogo Clinical Site 03
  • Hyogo Clinical Site 04
  • Kanagawa Clinical Site 01
  • Kanagawa Clinical Site 02
  • Kanagawa Clinical Site 03
  • Kanagawa Clinical Site 04
  • Osaka Clinical Site 03
  • Osaka Clinical Site 04
  • Osaka Clinical Site 02
  • Osaka Clinical Site 05
  • Osaka Clinical Site 06
  • Osaka Clinical Site 07
  • Saitama Clinical Site 01
  • Osaka Clinical Site 01
  • Tokyo Clinical Site 10
  • Tokyo Clinical Site 01
  • Tokyo Clinical Site 06
  • Tokyo Clinical Site 09
  • Tokyo Clinical Site 07
  • Tokyo Clinical Site 03
  • Tokyo Clinical Site 08
  • Tokyo Clinical Site 11
  • Tokyo Clinical Site 04
  • Tokyo Clinical Site 05
  • Tokyo Clinical Site 02
  • Kyoto Clinical Site 01

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ONO-8577 Arm

Active Comparator Arm

Placebo Arm

Arm Description

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

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

Oral administration of Placebo once a daily for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2017
Last Updated
October 21, 2020
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03106623
Brief Title
Study of ONO-8577 in Patients With Overactive Bladder
Official Title
Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
August 29, 2017 (Actual)
Study Completion Date
September 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ONO-8577 Arm
Arm Type
Experimental
Arm Description
Oral administration of ONO-8577 once a daily for 4 weeks
Arm Title
Active Comparator Arm
Arm Type
Active Comparator
Arm Description
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Oral administration of Placebo once a daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-8577
Intervention Description
Oral administration of ONO-8577 once a daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
solifenacin succinate + mirabegron
Intervention Description
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration of Placebo once a daily for 4 weeks
Primary Outcome Measure Information:
Title
Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)
Time Frame
Up to Week 4
Title
Pharmacokinetics (plasma concentration at one point on each visit)
Time Frame
Week 2 and 4
Title
Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)
Time Frame
Baseline and Week 2
Title
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)
Time Frame
Baseline, Week 2 and 4
Title
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours)
Time Frame
Baseline, Week 2 and 4
Title
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours)
Time Frame
Baseline, Week 2 and 4
Title
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours)
Time Frame
Baseline, Week 2 and 4
Title
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours)
Time Frame
Baseline, Week 2 and 4
Title
Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)
Time Frame
Week 2 and 4
Title
Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4
Time Frame
Week 2 and 4
Title
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition)
Time Frame
Baseline, Week 2 and 4
Title
Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )
Time Frame
Baseline, Week 2 and 4
Title
Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)
Time Frame
Baseline and Week 4
Title
Efficacy (Patient Global Impression at Week 4)
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hitoshi Kajitani
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Gunma Clinical Site 02
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Gunma Clinical Site 01
City
Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Hyogo Clinical Site 02
City
Akashi
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site 01
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site 03
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site 04
City
Takarazuka
State/Province
Hyogo
Country
Japan
Facility Name
Kanagawa Clinical Site 01
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site 02
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site 03
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site 04
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Osaka Clinical Site 03
City
Higashiosaka
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site 04
City
Ibaraki
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site 02
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site 05
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site 06
City
Toyonaka
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site 07
City
Toyonaka
State/Province
Osaka
Country
Japan
Facility Name
Saitama Clinical Site 01
City
Kumagaya
State/Province
Saitama
Country
Japan
Facility Name
Osaka Clinical Site 01
City
Osaka
State/Province
Takatsuki-shi
Country
Japan
Facility Name
Tokyo Clinical Site 10
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 01
City
Edogawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 06
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 09
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 07
City
Nerima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 03
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 08
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 11
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 04
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 05
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site 02
City
Suginami-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kyoto Clinical Site 01
City
Kyoto
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html

Learn more about this trial

Study of ONO-8577 in Patients With Overactive Bladder

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