A double-blind, placebo-controlled phase II study of Org 3770 (mirtazapine) in patients with fibromyalgia
- Conditions
- fibromyalgia
- Registration Number
- JPRN-jRCT2080221141
- Lead Sponsor
- MEIJI SEIKA KAISHA, LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 120
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method