JPRN-jRCT2080221141未知2 期
A double-blind, placebo-controlled phase II study of Org 3770 (mirtazapine) in patients with fibromyalgia
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •- 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.
研究者
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