Fibromyalgia
Conditions
Sponsors
Terasawa Tetsuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese (both sexes) 2. Outpatient 3. Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator) 4.Patients who meet the American College of Rheumatology Fibromyalgia Criteria
Exclusion criteria
Exclusion criteria: 1. Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease 2. Patients with pain other than FM that may affect assessments in this study 3. Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study 4. Patients with a past history of or concurrent malignant tumor within 3 years 5. Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Change in weekly mean of average pain score Safety: Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test | — |
Secondary
| Measure | Time frame |
|---|---|
| -Efficacy -Pharmacokinetics | — |
Contacts
Public ContactSupport Desk JP
Ono Pharmaceutical Co.,LTD.
Outcome results
None listed