A Clinical Study of ONO-1110 in Patients With Fibromyalgia

A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Fibromyalgia

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia

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.