Duloxetine (Cymbalta): for Fibromyalgia: An Open Label Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therpeutic Responsiveness to Duloxetine.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain Reduction
研究概览
简要总结
Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.
详细描述
Subjects will have skin biopsies taken and evaluated for specific pathologies. All subjects will undergo a treatment period with Duloxetine. The analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Treatment Arm
- •Fibromyalgia Diagnosis
- •Over the age of 18, under the age of 70
- •Understands English
- •Not Pregnant/planning to become pregnant
排除标准
- •No major psychiatric disorders
- •No major unconrolled systemic diseases which may require hospitalization in the next 6 months
- •Inclusion Criteria: Control Arm
- •Over the age of 18, under the age of 70
- •Understands English
- •Not Pregnant/planning to become pregnant
- •Exclusion Criteria: Control Arm
- •No major psychiatric disorders
- •No major unconrolled systemic diseases which may require hospitalization in the next 6 months
研究组 & 干预措施
Treatment
Subjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Pain Reduction
时间窗: 12 weeks
Changes in Pain measured by Numeric Pain Rating Scale over time. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer.
次要结局
未报告次要终点
研究者
Tobias Moeller-Bertram
Associate Clinical Professor of Anesthesia
University of California, San Diego