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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-8577 Arm | Experimental | Oral administration of ONO-8577 once a daily for 4 weeks |
|
| Active Comparator Arm | Active Comparator | Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks |
|
| Placebo Arm | Placebo Comparator | Oral administration of Placebo once a daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-8577 | Drug | Oral administration of ONO-8577 once a daily for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours) | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hitoshi Kajitani | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gunma Clinical Site 02 | Maebashi | Gunma | Japan | |||
| Gunma Clinical Site 01 |
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| solifenacin succinate + mirabegron |
| Drug |
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks |
|
| Placebo | Drug | Oral administration of Placebo once a daily for 4 weeks |
|
| 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 |
| 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 Urgency 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 ˂8 times of Micturitions Per 24 Hours at Week 2 and 4) | Week 2 and 4 |
| Efficacy (Percentage of Participants With Zero Incontinence Episodes at 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) | Baseline, Week 2 and 4 |
| Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) ) | Baseline, Week 2 and 4 |
| 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 |
| Takasaki |
| Gunma |
| Japan |
| Hyogo Clinical Site 02 | Akashi | Hyōgo | Japan |
| Hyogo Clinical Site 01 | Kobe | Hyōgo | Japan |
| Hyogo Clinical Site 03 | Kobe | Hyōgo | Japan |
| Hyogo Clinical Site 04 | Takarazuka | Hyōgo | Japan |
| Kanagawa Clinical Site 01 | Isehara | Kanagawa | Japan |
| Kanagawa Clinical Site 02 | Kamakura | Kanagawa | Japan |
| Kanagawa Clinical Site 03 | Sagamihara | Kanagawa | Japan |
| Kanagawa Clinical Site 04 | Yokohama | Kanagawa | Japan |
| Osaka Clinical Site 03 | Higashiosaka | Osaka | Japan |
| Osaka Clinical Site 04 | Ibaraki | Osaka | Japan |
| Osaka Clinical Site 02 | Osaka | Osaka | Japan |
| Osaka Clinical Site 05 | Suita | Osaka | Japan |
| Osaka Clinical Site 06 | Toyonaka | Osaka | Japan |
| Osaka Clinical Site 07 | Toyonaka | 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 06 | Itabashi-ku | Tokyo | Japan |
| Tokyo Clinical Site 09 | Nakano-ku | Tokyo | Japan |
| Tokyo Clinical Site 07 | Nerima-ku | Tokyo | Japan |
| Tokyo Clinical Site 03 | Ōta-ku | Tokyo | Japan |
| Tokyo Clinical Site 08 | Setagaya-ku | Tokyo | Japan |
| Tokyo Clinical Site 11 | Setagaya-ku | Tokyo | Japan |
| Tokyo Clinical Site 04 | Shinagawa-ku | Tokyo | Japan |
| Tokyo Clinical Site 05 | Shinagawa-ku | Tokyo | Japan |
| Tokyo Clinical Site 02 | Suginami-ku | Tokyo | Japan |
| Kyoto Clinical Site 01 | Kyoto | Japan |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| C520025 | mirabegron |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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