JPRN-jRCTs031210629进行中（未招募）未知
Efficacy and Safety of Mirogabalin for the Treatment as Add-On to NSAIDs in patients with Peripheral Neuropathic Pain caused by Cervical Spondylotic Radiculopathy : Multi-institutional, randomized, open, parallel-design and interventional Study - Miro-Cens
Hirai Takashi0 个研究点目标入组 140 人开始时间: 2022年2月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •[First stage enrollment (Screening)]
- •1.Patients diagnosed with cervical spondylotic radiculopathy at enrollment (separate diagnostic criteria are set)
- •2.Patients with upper limb pain associated with cervical spondylotic radiculopathy and continuing pain for more than 3 months before enrollment
- •3.Patients with a VAS value of 40 mm or more for upper limb pain at enrollment
- •4.Patients aged 20 years or older at the time of obtaining informed consent
- •5.Patients who can understand the procedure of this study, can answer Japanese questions appropriately without assistance, and can give their own written consent at their own free will to participate in the study
- •[Second stage enrollment (Randomization)]
- •1.Patients who have been continuously taking NSAIDs for at least 28 days prior to enrollment and have not changed dosage during that time
- •2.Patients with documented upper limb pain NRS for at least 4 days in the 7 days prior to enrollment and the average value of at least 4
排除标准
- •[First stage enrollment (Screening)]
- •1.Patients with severe pain other than cervical spondylotic radiculopathy at enrollment and considered difficult to assess
- •2.Patients with a diagnosis of cervical spondylotic myelopathy at enrollment
- •3.Patients with a history of surgery of the cervical spine at enrollment
- •4.Patients with creatinine clearance (CLcr) <30 mL/min at enrollment
- •5.Patients with a history of hypersensitivity to components of mirogabalin, pregabalin, and gabapentin
- •6.Patients with a complicated malignancy who are under treatment or to have surgery during study period at enrollment
- •7.Patients with complicated infections and considered to have an impact on the evaluation in this study
- •8.Patients with complicated painful fractures
- •9.Patients with complicated serious liver, kidney, and heart disease who are difficult to participate in this study
- •10.Patients taking mirogabalin within 28 days before obtaining informed consent
- •11.Patients who are pregnant or possibly pregnant at the time of obtaining informed consent, patients who are breastfeeding at the time of obtaining informed consent, and patients who intend to become pregnant within 6 months after obtaining informed consent
- •12.Patients who have at least 11 points for physicians, or at least 10 points for physicians and at least 15 points for patients on the Brief Scale for psychiatric problems in orthopaedic patients (BS-POP) at enrollment
- •13.Patients participating in or planned to participate in other intervention studies at enrollment
- •14.Other patients judged by the principal investigator or subinvestigator to be ineligible for participation in this study
- •[Second stage enrollment (Randomization)]
- •1.Patients with severe pain other than cervical spondylotic radiculopathy at enrollment and considered difficult to assess
- •2.Patients taking prohibited concomitant medications within 14 days before enrollment
- •3.Patients receiving prohibited concomitant therapy within 14 days before enrollment
- •4.Other patients judged by the principal investigator or the subinvestigator to be ineligible for participation in this study
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