fibromyalgia
Conditions
Interventions
investigational material(s)
Generic name etc : Org 3770 tablet 15 mg
INN of investigational material : mirtazapine
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Inv
Sponsors
MEIJI SEIKA KAISHA, LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with fibromyalgia who meet the American College of Rheumatology(ACR) classification criteria for fibromyalgia. - The VAS score for pain is >=40 mm at the initiation of observation period and at the initiation of treatment period. - The average NRS score for pain is >=4 during the observation period. - Patients who received sufficient explanation on the objectives, method and meaning etc. of this study and can give voluntary consent in writing. etc.
Exclusion criteria
Exclusion criteria: - Placebo responder at the observation period. - Patient with pain from other diseases or pathologies than fibromyalgia. - Patient with inflammatory musculoskeletal disease, rheumatic disease except fibromyalgia. - Patients with treated but uncontrolled hepatic disease, renal disease, cardiovascular disease, respiratory disease, gastrointestinal disease, endocrine disease, or cerebrovascular disease, or other clinically significant concomitant physical depression. - Patients with or with the history of schizophrenia, other psychotic disorders, or manic depression. - Patients with diagnosed depression who are treated with medication. - Patients with or with the history of convulsive disorders such as epilepsy. - Patients who took a MAO inhibitor within one week (7days) before the initiation of observation period. - Patients who are pregnant or breast-feeding, or who wish to be pregnant during the study. - Patients who have participated in any other clinical study within 3 month(90 days) before the initiation of observation period. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS, VAS Change from baseline | — |
Outcome results
None listed