Study of ONO-8577 in Patients With Overactive Bladder

May 2, 2024 updated by: Ono Pharmaceutical Co. Ltd

Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan
        • Kyoto Clinical Site 01
    • Gunma
      • Maebashi, Gunma, Japan
        • Gunma Clinical Site 02
      • Takasaki, Gunma, Japan
        • Gunma Clinical Site 01
    • Hyogo
      • Akashi, Hyogo, Japan
        • Hyogo Clinical Site 02
      • Kobe, Hyogo, Japan
        • Hyogo Clinical Site 01
      • Kobe, Hyogo, Japan
        • Hyogo Clinical Site 03
      • Takarazuka, Hyogo, Japan
        • Hyogo Clinical Site 04
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Kanagawa Clinical Site 01
      • Kamakura, Kanagawa, Japan
        • Kanagawa Clinical Site 02
      • Sagamihara, Kanagawa, Japan
        • Kanagawa Clinical Site 03
      • Yokohama, Kanagawa, Japan
        • Kanagawa Clinical Site 04
    • Osaka
      • Higashiosaka, Osaka, Japan
        • Osaka Clinical Site 03
      • Ibaraki, Osaka, Japan
        • Osaka Clinical Site 04
      • Osaka-shi, Osaka, Japan
        • Osaka Clinical Site 02
      • Suita, Osaka, Japan
        • Osaka Clinical Site 05
      • Toyonaka, Osaka, Japan
        • Osaka Clinical Site 06
      • Toyonaka, Osaka, Japan
        • Osaka Clinical Site 07
    • Saitama
      • Kumagaya, Saitama, Japan
        • Saitama Clinical Site 01
    • Takatsuki-shi
      • Osaka, Takatsuki-shi, Japan
        • Osaka Clinical Site 01
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Tokyo Clinical Site 10
      • Edogawa-ku, Tokyo, Japan
        • Tokyo Clinical Site 01
      • Itabashi-ku, Tokyo, Japan
        • Tokyo Clinical Site 06
      • Nakano-ku, Tokyo, Japan
        • Tokyo Clinical Site 09
      • Nerima-ku, Tokyo, Japan
        • Tokyo Clinical Site 07
      • Ota-ku, Tokyo, Japan
        • Tokyo Clinical Site 03
      • Setagaya-ku, Tokyo, Japan
        • Tokyo Clinical Site 08
      • Setagaya-ku, Tokyo, Japan
        • Tokyo Clinical Site 11
      • Shinagawa-ku, Tokyo, Japan
        • Tokyo Clinical Site 04
      • Shinagawa-ku, Tokyo, Japan
        • Tokyo Clinical Site 05
      • Suginami-ku, Tokyo, Japan
        • Tokyo Clinical Site 02

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ONO-8577 Arm
Oral administration of ONO-8577 once a daily for 4 weeks
Drug: ONO-8577
Oral administration of ONO-8577 once a daily for 4 weeks
Active Comparator: Active Comparator Arm
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
Drug: solifenacin succinate + mirabegron
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
Placebo Comparator: Placebo Arm
Oral administration of Placebo once a daily for 4 weeks
Drug: Placebo
Oral administration of Placebo once a daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)
Time Frame: Baseline and Week 4
Baseline and Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)
Time Frame: Up to Week 4
Up to Week 4
Pharmacokinetics (plasma concentration at one point on each visit)
Time Frame: Week 2 and 4
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
Baseline and Week 2
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
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)
Time Frame: Baseline, Week 2 and 4
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)
Time Frame: Baseline, Week 2 and 4
Baseline, Week 2 and 4
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
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)
Time Frame: Baseline, Week 2 and 4
Baseline, Week 2 and 4
Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)
Time Frame: Week 2 and 4
Week 2 and 4
Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4
Time Frame: Week 2 and 4
Week 2 and 4
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
Baseline, Week 2 and 4
Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )
Time Frame: Baseline, Week 2 and 4
Baseline, Week 2 and 4
Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)
Time Frame: Baseline and Week 4
Baseline and Week 4
Efficacy (Patient Global Impression at Week 4)
Time Frame: Week 4
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hitoshi Kajitani, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONO-8577-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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