EUCTR2007-001743-21-DE
进行中（未招募）
不适用
A PHASE II DOUBLE BLIND MODIFIED CROSS OVER DESIGN STUDY EVALUATING THE EFFICACY AND SAFETY OF TRIMETAZIDINE (GENERICS UK LIMITED) AND PLACEBO IN THE TREATMENT OF FIBROMYALGIA
Generics (UK) Ltd.0 个研究点2007年9月19日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Fibromyalgia
- 发起方
- Generics (UK) Ltd.
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Subjects fulfilling the following criteria are eligible for participation in the study:
- •(1\)Male or female
- •(2\)Age equal or more than18 years
- •(3\)Body weight between 60 and 130 kg for males and 50 and 110 kg for females. In addition the BMI range limit of 18 – 32 kg/m2 (both inclusive) is applicable .
- •(4\)Diagnosed by an expert as having primary fibromyalgia.
- •(5\)Newly diagnosed subjects or uncontrolled subjects currently experiencing pain (score \> 5 \< 8 on the VAS)
- •(6\)No significant concurrent illness apart from fibromyalgia
- •(7\)Available for the entire study period and are willing to adhere to the protocol requirements.
- •(8\)Have signed consent form after the nature of the study has been fully explained.
- •Are the trial subjects under 18? no
排除标准
- •Subjects who meet one of more of the following criteria are not eligible:
- •(1\)History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
- •(2\)History of autoimmune disease or inflammatory arthropathy (e.g. rheumatoid arthritis, systemic lupus erythematosus) as evidenced either clinically or by serology (elevated rheumatoid factor, antinuclear antibody etc.)
- •(3\)Clinical and laboratory evidence or history of hepatitis B or C (antibodies)
- •(4\)Subject is HIV\-seropositive
- •(5\)Change in medication within the last 4 weeks prior to the first administration of the test product and throughout the study
- •(6\)History of major psychiatric disease.
- •(7\)Subjects with any other disease, which in the opinion of the investigator is likely to affect the results of the study or subject safety.
- •(8\)Subjects with screening laboratory test values greater than 2\.5 times the normal value.
- •(9\)Recent history (\<1 year) or presence of alcohol abuse or substance abuse. A bit extreme ..no alcohol for a year prior to study?
结局指标
主要结局
未指定
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