A Clinical Study of ONO-1110 in Patients With Fibromyalgia
NCT ID: NCT06752590
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2025-03-26
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ONO-1110
ONO-1110 tablets once a day
ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Placebo
Placebo tablets once daily
Interventions
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ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Eligibility Criteria
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Inclusion Criteria
* Outpatient
* Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)
* Patients who meet the American College of Rheumatology Fibromyalgia Criteria
Exclusion Criteria
* Patients with pain other than FM that may affect assessments in this study
* Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
* Patients with a past history of or concurrent malignant tumor within 3 years
* Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Kimura Clinic
Nagoya, Aichi-ken, Japan
National Hospital Organization Shimoshizu National Hospital
Yotsukaidō, Chiba, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Shirasawa Orthopedic Clinic
Morioka, Iwate, Japan
Kokorotoitami Clinic
Kawasaki, Kanagawa, Japan
Women's Clinic Luna
Yokohama, Kanagawa, Japan
Miyashita Rheumatology Clinic
Ōmura, Nagasaki, Japan
Medical Corporation Fujigaki Clinic
Ōita, Oita Prefecture, Japan
Ai Sakura Clinic
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Japanese Red Cross Okayama Hospital
Okayama, , Japan
Hayaishi Hospital
Osaka, , Japan
Morimoto Clinic
Osaka, , Japan
Shizuoka Rehab Pain Clinic
Shizuoka, , Japan
Fukuwa Clinic
Tokyo, , Japan
Ginza Neurological Clinic
Tokyo, , Japan
Himenotomomi Clinic
Tokyo, , Japan
Ikebukuro Internal Medicine
Tokyo, , Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Juntendo University Nerima Hospital
Tokyo, , Japan
Nihonbashi Medical
Tokyo, , Japan
Nishiogi Pain Clinic
Tokyo, , Japan
Sanno Hospital
Tokyo, , Japan
Tokyo-Eki Center-Building Clinic
Tokyo, , Japan
Yakushinkai Healthcare Association Kandasudacho Dermatology
Tokyo, , Japan
Countries
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Central Contacts
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Other Identifiers
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jRCT2031240522
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-1110-05
Identifier Type: -
Identifier Source: org_study_id
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