NCT00757679已完成2 期
Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-controlled Clinical Trial in Fibromyalgia Out-patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.
研究概览
简要总结
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients
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 (Participant, Investigator)
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
- 否
入选标准
- •patient with FMS according to the 1990 ACR criteria
- •patient willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsivants, opiates
- •patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics
排除标准
- •severe psychiatric illness
- •current Major Depressive Episode (MDE)
- •significant risk of suicide
- •history of substance abuse
- •myocardial infarction in the past 24 months
- •active cardiac disease
- •congestive heart failure
- •prosthetic heart valve
- •haemodynamically significant valvular heart disease
- •known cardiac rhythm anomalies or conduction abnormalities
- •unstable and uncontrolled arterial hypertension or supine arterial blood pressure over 160/90 mmHg
- •pulmonary dysfunction
- •active liver disease
- •renal impairment
- •documented autoimmune disease
- •current systemic infection
- •active cancer, except basal cell carcinoma or current cancer therapy
- •severe sleep apnoea
- •active peptic ulcer or inflammatory bowel disease (except IBS)
- •unstable endocrine disease
- •pregnancy or breastfeeding
- •concomitant use of non selective MAO inhibitors, MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs, NARIs, SNRIs, epinephrine, norepinephrine, clonidine and related compounds, long-acting benzodiazepines
- •concomitant use of oral anticoagulants, anticonvulsants, type Ic antiarrythmics, lithium
- •concomitant use of hypericum and SAMe
- •concomitant use of digitalis preparations
- •regular use of centrally-acting muscle relaxants
- •concomitant use of strong analgesics, including tramadol, codeine or opiates
- •any factor known to affect the HPA axis or autonomic function such as cigarette smoking (regularly over 25 cigarettes a day)
研究组 & 干预措施
Milnacipran
Experimental
干预措施: Milnacipran (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.
时间窗: 7 weeks
次要结局
- The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo(7 weeks)
- The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations(7 weeks)
- The safety/tolerability and compliance of 8 weeks of treatment with milnacipran(8 weeks)
- The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations(7 weeks)
研究者
研究点 (1)
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