JPRN-jRCT1031210142招募中未知
Randomized controlled trials of the efficacy of duloxetine for central sensitized hand osteoarthritis patients
kohata kazuhiro0 个研究点目标入组 140 人开始时间: 2021年6月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 25age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Osteoarthritis patient (Kellgren Lawrence classification grade more than 2 with high central sensitization (CSI 30 or more) who have had pain for 3months or more and have been diagnosed with osteoarthritis based on the latest diagnostic criteria.
- •2) Those who are competent in the Japanese language and have ability to fill out quetionnaires
- •3) Aged more than 25 years
- •4) no matter of gender
- •5) Those who have received sufficient explanation for participating in this study, and have obtained the consent with sufficient understanding
- •6) Those who can come to outpatient clinic according to the research schedule
排除标准
- •1) Persons taking duloxetine hydrochloride or mechanism of action like duloxetine hydrochloride (serotonin noradrenaline reuptake inhibitor) within 7 days of obtaining consent
- •2) Persons with uncontrolled hypertension, severe liver damage, renal damage, or cardiovascular disease (judged by referring to Grade 3 of JCOG ,CTCAE version 5.0)
- •3) Persons with a history of hypersensitivity to the duloxetine hydrochloride or acetaminophen
- •4) Patients administering monoamine oxidase (MAO) inhibitors within two weeks
- •5) Patients with uncontrolled closed angle glaucoma
- •6) Persons with a history of serious side effects or serious drug allergies such as anaphylactic shock
- •7) Patients who fall under the precautions for the package insert (Patients with difficulty of urinating due to such as benign prostatic hyperplasia, Excessive alcohol drinkers, Patients with suicidal ideation or history of suicide attempt, Patient with manic depression, Patients with organic brain disorders or a predisposition to schizophrenia)
- •8) Persons with a history of trauma (such as fractures) within 6 months prior to obtaining consent
- •9) Patients who underwent surgery for the underlying disease within 6 months prior to obtaining consent
- •10) Patients who plan to undergo surgical therapy in their study period
- •11) Persons who are or may be pregnant
- •12) Persons who are nursing mothers
- •13 In addition, those who are judged by the research-responsible (sharing) doctor to be inappropriate for participation in this research
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