fibromyalgia
Conditions
Interventions
investigational material(s)
Generic name etc : Org 3770 tablet 15mg
INN of investigational material : mirtazapine
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Inve
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with fibromyalgia as defined with "The American College of Rheumatology 1990 Criteria", who meet all inclusion criteria and do not meet all exclusion criteria. - Patients with a score >= 40 mm on VAS pain score at screening visit and at baseline visit - Patients with a score >= 4 on NRS pain score at baseline visit - Patients who have been explained study objectives, methods and other aspects of study, and can give voluntary consent in writing etc.
Exclusion criteria
Exclusion criteria: - Patients with pain disorder except fibromyalgia - Patients with inflammatory or rheumatologic disease - Patients with treated but uncontrolled hepatic, renal, cardiovascular, respiratory, gastrointestinal, endocrine, or cerebrovascular diseases, or other clinically significant concomitant physical diseases - Patients with schizophrenia, other psychotic disease or bipolar disorder, and patients with these histories - Patients with major depression disorder - Patients with epilepsy or spasm disease, and patients with these histories - Patients who had received MAO inhibitor within 14 days prior to baseline visit - Pregnant patients, patients who breast-feeds a baby and patients who want to be pregnant - Patients who had received other investigational drugs within 90 days prior to screening visit etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS Amount of change from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS, and so on Amount of change from baseline | — |
Outcome results
None listed