EUCTR2013-004313-41-NL进行中（未招募）1 期
Effect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty - Duloxetine In OsteoArthritis study (DOA-study)
MCG0 个研究点开始时间: 2014年2月24日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Primary Osteoarthritis (based on clinical and radiological ACR-criteria)
- •2.Age >18 years
- •3.A neuropathic or at least a mixed neuropathic / noiciceptive pain phenotype (m-painDETECT-score >12)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •General exclusion criteria:
- •1.Surgical hip or knee joint procedures less than 1 year previously
- •2.Cognitive and/or neurological disorders that could interfere strongly with questionnaire surveys (e.g. Dementia)
- •3.Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.
- •4.Planned or intended to perform THA or TKA within the study duration (present planned arthroplasty not included)
- •5.A history of peripheral nerve injury
- •6.Previous exposure to Duloxetine
- •Duloxetine related exclusion criteria:
- •7.Allergy to study medication or compounds of the Duloxetine capsule (or another SNRI);
- •8.History of peptic ulcer disease or bleeding disorder (or other substantial risk factor for bleeding)
- •9.Psychiatric disorders, other than depression;
- •10.Severe depression (HADS score >15 on depression subscale);
- •11.A history of alcohol or other substance abuse (excluding nicotine and caffeine) or dependence within the five years prior to enrollment;
- •12.Currently pregnant or lactating, our planned to become pregnant within the study period
- •13.History of cardiac arrhythmias, cardiac failure, myocardial infarct;
- •14.impaired function of the liver, or known cirrhosis or liver transplantation;
- •15.severe renal impairment, or had renal transplantation or receiving renal dialysis;
- •16.Hyponatraemia, or a history of frequent hyponatremias;
- •17.History of uncontrolled hypertension, history of glaucoma (or with increased intraocular pressure) ,uncontrolled thyroid disease and a history of uncontrolled seizures;
- •18.Usage of non selective monoamine oxidase (MAO) inhibitors, TCA’s , SSRIs, SNRIs in the last year;
- •19.Usage of strong CYP1A2-inhibitors
研究者
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