ACTRN12619001082190招募中3 期
Venlafaxine compared to duloxetine for the treatment of osteoarthritis pain: A double-blind, randomised, non-inferiority trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit(—)
- 性别
- All
入选标准
- •Males and females at least 40 years old who have radiographic evidence of knee osteoarthritis and meet the American College of Rheumatology clinical criteria for the diagnosis of knee osteoarthritis.
- •A history of knee pain for > 14 days days of each month for 3 months or more.
- •A brief pain inventory average pain rating of at least 4/10 at the time of initial screening
排除标准
- •Current use of antidepressant medication or any other medication with a serotonergic effect; use of a MAOI inhibitor in the last 14 days; narrow-angle glaucoma; BMI > or = to 40; diagnosis of any other type of arthritis; joint injection or surgery on the index knee within the last 3 months; impending surgery in the next 3 months; medical contraindication to the use of rescue medications (acetaminophen and NSAIDs); patients taking any excluded medications that cannot be discontinued; women who are pregnant, breast feeding or planning to get pregnant; previous diagnosis of a major psychiatric disorder; history of alcoholism; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 100 IU/L or total bilirubin > 27.4 umol/L; glomerular filtration rate of < 30ml/min; a history of myocardial infarction in the last 12 months, QTc interval > 500ms, unstable coronary artery disease or recent unexplained cardiac symptoms; uncontrolled hypertension (> or = to 140mmHg systolic or > or = to 90mmHg diastolic BP); a history of seizures; a history of multiple falls in the last 12 months; current use of warfarin; an inability to perform psychophysical testing.
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