NCT00791739已完成4 期
Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
研究概览
简要总结
The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria
- •written, informed consent
- •able to understand and comply with the requirements of the study
排除标准
- •pregnancy or breastfeeding
- •unwillingness to discontinue other prescribed medications before entering in the study
- •patients who had previously received trazodone without improvement or who did not tolerate the drug
- •patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase II of the study)
研究组 & 干预措施
one arm study
Experimental
干预措施: trazodone, pregabalin (Drug)
结局指标
主要结局
Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
时间窗: Baseline, 6, 12, 18 and 24 weeks
次要结局
- Change from baseline to endpoint in the scores of the Pittsburgh Sleep Quality Inventory, the Brief Pain Inventory, the Beck Depression Inventory, and the Hospital Anxiety and Depression Scale(Baseline, 6, 12, 18, and 24 weeks)
- Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events(baseline, 6, 12, 18, and 24 weeks)
研究者
Elena Pita Calandre
Professor of Pharmacology
Universidad de Granada
研究点 (1)
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