Overactive BladderPhase 2NCT03106623

Study of ONO-8577 in Patients With Overactive Bladder

A Phase 2 study testing ONO-8577 and solifenacin succinate + mirabegron in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd. at 30 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Overactive Bladder
What is being tested?: ONO-8577 and solifenacin succinate + mirabegron
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 30 sitesJapan
Study dates: 7 Apr 2017to 26 Sep 2017
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient with symptoms of overactive bladder for ≥6 months

Who cannot join

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

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

Japan30 sites

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

Other trials in Japan

About this study

Official title: 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

Conditions: Overactive Bladder
Being tested: ONO-8577, solifenacin succinate + mirabegron, Placebo
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ONO-8577Drug
Oral administration of ONO-8577 once a daily for 4 weeks
solifenacin succinate + mirabegronDrug
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
PlaceboDrug
Oral administration of Placebo once a daily for 4 weeks

Study groups in NCT03106623
Study group	Role	What they receive
ONO-8577 Arm	Experimental	Oral administration of ONO-8577 once a daily for 4 weeks Receives: Drug: ONO-8577
Active Comparator Arm	Active comparator	Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks Receives: Drug: solifenacin succinate + mirabegron
Placebo Arm	Placebo comparator	Oral administration of Placebo once a daily for 4 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 201726 Sep 2017

First posted10 Apr 2017
Study start7 Apr 2017
Primary completion29 Aug 2017
Study completion26 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overactive BladderStudies of the same condition, open and under way.
More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03106623
Sponsor's protocol ID: ONO-8577-02
Status last verified: May 2024
First submitted: 15 Mar 2017
Last updated: 3 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder
ClinicalTrials.gov ID: NCT03106623
Acronym / sponsor ID: ONO-8577-02
Conditions: Overactive Bladder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Apr 2017 (actual)
Primary completion: 29 Aug 2017 (actual)
Study completion: 26 Sep 2017 (actual)
First posted: 10 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ONO-8577 Arm	Experimental	Drug: ONO-8577Oral administration of ONO-8577 once a daily for 4 weeks
Active Comparator Arm	Active comparator	Drug: solifenacin succinate + mirabegronOral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
Placebo Arm	Placebo comparator	Drug: PlaceboOral administration of Placebo once a daily for 4 weeks

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patient with symptoms of overactive bladder for ≥6 months

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ONO-8577Oral administration of ONO-8577 once a daily for 4 weeks	Drug	ONO-8577 Arm
solifenacin succinate + mirabegronOral administration of solifenacin succinate and mirabegron once a daily for 4 weeks	Drug	Active Comparator Arm
PlaceboOral administration of Placebo once a daily for 4 weeks	Drug	Placebo Arm

Primary outcome

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

14 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Individual participant dataSharing planned: No

Related trials for Overactive Bladder

Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
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Recruiting
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Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hitoshi Kajitani study director

Ono Pharmaceutical Co., Ltd.

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ONO-8577 and solifenacin succinate + mirabegron in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd. at 30 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours) (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03106623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.