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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240504 | Registry Identifier | Japan Registry of Clinical Trials |
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To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia
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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 (last 7-day mean of past 24-hour average pain scores [NRS] in the pain diary) from baseline to Week 8 of the treatment period | Up to 15 weeks | |
| Adverse Events | Up to 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weekly mean of average pain score from baseline to each week | Up to 15 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 |
|---|---|---|---|---|---|---|
| Kamezawa Clinic | Aichi | Japan | ||||
| Kimura Clinic |
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| Drug |
Placebo tablets once daily |
|
| Up to 15 weeks |
| Change in weekly mean of worst pain score (last 7-day mean of past 24-hour worst pain scores [NRS] in the pain diary) from baseline to each week | Up to 15 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 15 weeks |
| Change in Brief pain inventory-short form (BPI-SF) score from baseline | Up to 15 weeks |
| Change in Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) score from baseline | Up to 15 weeks |
| Patient Global Impression of Change (PGIC) score | Up to 15 weeks |
| Change in Hospital Anxiety and Depression Scale (HADS) score from baseline | Up to 15 weeks |
| Plasma ONO-1110 concentrations | Up to 15 weeks |
| Aichi |
| Japan |
| Fukuoka Tokushukai Hospital | Fukuoka | Japan |
| Southern Tohoku General Hospital | Fukushima | Japan |
| Central Japan International Medical Center | Gifu | Japan |
| National Hospital Organization Kure Medical Center | Hiroshima | Japan |
| National Hospital Organization Hokkaido Medical Center | Hokkaido | Japan |
| Nishinomiya Municipal Central Hospital | Hyōgo | Japan |
| Mito Saiseikai General Hospital | Ibaraki | Japan |
| Kawasaki Municipal Hospital | Kanagawa | Japan |
| Konan Hidamari Pain Clinic | Kanagawa | Japan |
| Nomura Dermatology Clinic | Kanagawa | Japan |
| Tai Clinic | Kanagawa | Japan |
| Yokohama City Minato Red Cross Hospital | Kanagawa | Japan |
| Junwakai Memorial Hospital | Miyazaki | Japan |
| Medical Corporation Toyama Dermatology | Miyazaki | Japan |
| Yuaikai Tomishiro Chuo Hospital | Okinawa | Japan |
| Morimoto Clinic | Osaka | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Osaka | Japan |
| Osaka Metropolitan University Hospital | Osaka | Japan |
| Medical Corporation Fujigaki Clinic | Ōita | Japan |
| Chutoen General Medical Center | Shizuoka | Japan |
| Shizuoka Rehabili Pain Clinic | Shizuoka | Japan |
| Fukuuchi Pain Clinic | Tokyo | Japan |
| Fukuwa Clinic | Tokyo | Japan |
| Futaki Skin Care Clinic | Tokyo | Japan |
| Juntendo University Hospital | Tokyo | Japan |
| Mitaka Pain Clinic | Tokyo | Japan |
| Nishiogi Pain Clinic | Tokyo | Japan |
| Tokyo-Eki Center-Building Clinic | Tokyo | Japan |
| Yamanashi Prefectural Central Hospital | Yamanashi | Japan |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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