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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240522 | Registry Identifier | Japan Registry of Clinical Trials |
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To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia
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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 8 of the treatment period | Up to 16 weeks | |
| Adverse events | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weekly mean of average pain score from baseline in each week | Up to 16 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 |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Nagakute | Aichi-ken | Japan | |||
| Kimura Clinic |
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| Drug |
Placebo tablets once daily |
|
| Up to 16 weeks |
| Change in weekly mean of worst pain score from baseline to each week | Up to 16 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 16 weeks |
| Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline | Up to 16 weeks |
| Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline | Up to 16 weeks |
| Change in Patient Global Impression of Change (PGIC) score from baseline | Up to 16 weeks |
| Change in Hospital Anxiety and Depression Scale (HADS) score from baseline | Up to 16 weeks |
| Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline | Up to 16 weeks |
| Plasma ONO-1110 concentrations | Up to 16 weeks |
| Nagoya |
| Aichi-ken |
| Japan |
| National Hospital Organization Shimoshizu National Hospital | Yotsukaidō | Chiba | Japan |
| Ai Sakura Clinic | Fukuoka | Fukuoka | Japan |
| Sapporo City General Hospital | Sapporo | Hokkaido | Japan |
| Mayflower Hospital | Katō | Hyōgo | Japan |
| Shirasawa Orthopedic Clinic | Morioka | Iwate | Japan |
| Kokorotoitami Clinic | Kawasaki | Kanagawa | Japan |
| Women's Clinic Luna | Yokohama | Kanagawa | Japan |
| Junwakai Memorial Hospital | Miyazaki | Miyazaki | Japan |
| Miyashita Rheumatology Clinic | Ōmura | Nagasaki | Japan |
| Medical Corporation Fujigaki Clinic | Ōita | Oita Prefecture | Japan |
| Japanese Red Cross Okayama Hospital | Okayama | Okayama-ken | Japan |
| Hayaishi Hospital | Osaka | Osaka | Japan |
| Morimoto Clinic | Osaka | Osaka | Japan |
| Shizuoka Rehab Pain Clinic | Shizuoka | Shizuoka | Japan |
| Fukuwa Clinic | Tokyo | Tokyo | Japan |
| Ginza Neurological Clinic | Tokyo | Tokyo | Japan |
| Himenotomomi Clinic | Tokyo | Tokyo | Japan |
| Ikebukuro Internal Medicine | Tokyo | Tokyo | Japan |
| Juntendo Tokyo Koto Geriatric Medical Center | Tokyo | Tokyo | Japan |
| Juntendo University Hospital | Tokyo | Tokyo | Japan |
| Juntendo University Nerima Hospital | Tokyo | Tokyo | Japan |
| Nihonbashi Medical | Tokyo | Tokyo | Japan |
| Nishiogi Pain Clinic | Tokyo | Tokyo | Japan |
| Sanno Hospital | Tokyo | Tokyo | Japan |
| Tokyo-Eki Center-Building Clinic | Tokyo | Tokyo | Japan |
| Toyama University Hospital | Toyama | Toyama | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Yakushinkai Healthcare Association Kandasudacho Dermatology | Tokyo | Japan |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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