NCT00377039已完成2 期
A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Parallel Group Exploratory Study to Investigate the Efficacy, Safety and Tolerability of AD 337 in the Treatment of Fibromyalgia in Female Subjects.
Sosei1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
研究概览
简要总结
This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Meet ACR 1990 criteria for classification of Fibromyalgia
- •Able and willing to discontinue CNS active therapies
排除标准
- •If pain is NOT primarily due to Fibromyalgia
- •Current or prior history of serious psychiatric disorder
- •Pregnant/breastfeeding
- •QTc > 470ms
- •Failure to respond to 2 or more adequate regimes of different classes of antidepressants.
结局指标
主要结局
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
次要结局
- These will be
- FIQ Total score at weeks 1, 2, 3, at end of study and overall
- FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall
- Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall
- Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall
- Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall
- Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall
研究者
研究点 (1)
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