Overview
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia
Eligibility
Inclusion Criteria:
- Japanese (both sexes)
- 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 inflammatory arthritis, infectious arthritis, or autoimmune disease
- 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.