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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240558 | Registry Identifier | Japan Registry of Clinical Trials |
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To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-1110 | Experimental | ONO-1110 tablets once a day |
|
| Placebo | Placebo Comparator | Placebo tablets once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-1110 | Drug | ONO-1110 tablets once a day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weekly mean of average pain score from baseline to Week 12 of the treatment period | Up to 20 weeks | |
| Adverse events | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weekly mean of average pain score from baseline in each week | Up to 20 weeks | |
| 30%- and 50%-responder rates based on the weekly mean of average pain score | proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | Japan | |||
| Harasanshin Hospital |
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| Drug |
Placebo tablets once daily |
|
| Up to 20 weeks |
| Change in weekly mean of worst pain score from baseline to each week | Up to 20 weeks |
| 30%- and 50%-responder rates based on the weekly mean of worst pain score | proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively | Up to 20 weeks |
| Change in Interstitial cystitis symptom index (ICSI) score from baseline | Up to 20 weeks |
| Change in Interstitial cystitis problem index (ICPI) score from baseline | Up to 20 weeks |
| Change in Average frequency of urination per day from baseline | Up to 20 weeks |
| Change in Frequency of nocturnal urination per day from baseline | Up to 20 weeks |
| Change in Mean volume voided per micturition in a day from baseline | Up to 20 weeks |
| Change in Maximum volume voided per micturition in a day from baseline | Up to 20 weeks |
| Change in Number of urgency episodes per day from baseline | Up to 20 weeks |
| Change in Patient Global Impression of Change (PGIC) score from baseline | Up to 20 weeks |
| Change in SF-12v2 score from baseline | Up to 20 weeks |
| Change in Hospital Anxiety and Depression Scale (HADS) score from baseline | Up to 20 weeks |
| Plasma ONO-1110 concentrations | Up to 20 weeks |
| Fukuoka |
| Fukuoka |
| Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | Japan |
| Japanese Red Cross Gifu Hospital | Gifu | Gifu | Japan |
| Kurosawa Hospital Health Park Clinic | Takasaki | Gunma | Japan |
| Niimura Hospital | Kagoshima | Kagoshima-ken | Japan |
| Kanto Rosai Hospital | Kawasaki | Kanagawa | Japan |
| Rakuwakai Marutamachi Hospital | Kyoto | Kyoto | Japan |
| Ueda Clinic | Kyoto | Kyoto | Japan |
| Izumi Chuo Hospital | Sendai | Miyagi | Japan |
| Shinshu University Hospital | Matsumoto | Nagano | Japan |
| Nakamura Hospital | Beppu | Oita Prefecture | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | Japan |
| Nanri Urological Clinic | Saga | Saga-ken | Japan |
| The Jikei University Hospital | Minato-Ku | Tokyo | Japan |
| Kyorin University Hospital | Mitaka | Tokyo | Japan |
| The University Of Tokyo Hospital | Tokyo | Tokyo | Japan |
| Toyama Rosai Hospital | Uozu | Toyama | Japan |
| University Of Yamanashi Hospital | Chūō | Yamanashi | Japan |
| Nagasaki University Hospital | Nagasaki | Japan |