ACTRN12619000878178尚未招募2 期
A randomised controlled trial of venlafaxine to treat patients with knee osteoarthritis pain
niversity of Tasmania0 个研究点目标入组 116 人开始时间: 2019年6月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
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 80 Years（—）
- 性别
- All
入选标准
- •1.Age 40 to 80 years.
- •2.Knee pain for greater than or equal to 14 days of each month for >3 months.
- •3.Significant knee pain on most days (defined as a visual analogue scale (VAS) >40mm) on 100mm VAS pain.
- •4.Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a rheumatologist.
排除标准
- •1.Severe knee OA (defined as joint space narrowing (JSN) on X-ray as Grade 3 using the OARSI atlas)
- •2.Prior knee joint replacement surgery.
- •3.Arthroscopy or open surgery in the study knee <12 months.
- •4.Intra-articular steroid injection <3 months.
- •5.Inflammatory arthritis (gout, rheumatoid arthritis, juvenile arthritis, etc).
- •6.Patients with a psychiatric disorder including major depressive disorder (Patient Health Questionnaire-9 score (PHQ-9)>9).
- •7.Contraindication to venlafaxine use including:
- •Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation;
- •Current use of opioid medication;
- •Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs).
- •History of seizures.
- •Current use of venlafaxine or other antidepressants, amiodarone or domperidone.
- •Pregnancy or breastfeeding.
- •High cholesterol (total cholesterol >13.3 mmol/l).
- •Hyponatremia (low amount of sodium in the blood <135 mmol/L).
- •Increased risk of bleeding due to clotting disorder;
- •History of increased intra-ocular pressure or closed angle glaucoma.
- •Severe uncontrolled high blood pressure (supine diastolic blood pressure (SDBP) greater than or equal to 90 mm Hg).
- •Heart attack within the last 3 months.
- •Cirrhosis of the liver or abnormal liver function (alanine transaminase (ALT) 3x upper normal limit).
- •Mild to moderate kidney impairment (estimated glomerular filtration rate (eGFR) <89 ml/min per 1.73 m2).
- •8.Inability to provide informed consent.
研究者
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