jRCTs061220102进行中（未招募）不适用
Efficacy and Safety for Mirogabalin Treatment as Add-On to NSAIDs with Neuropathic Pain patients caused by Lumbar Disc Herniation : An Exploratory Study
未提供0 个研究点目标入组 180 人开始时间: 2023年3月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 主要终点
- Change in lower limb pain NRS
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients diagnosed with lumbar disc herniation by MRI imaging findings by the time of enrollment (Visit 1)
- •Patients with lower limb pain (including buttocks pain) with NRS of 4 or more due to neuropathic pain associated with lumbar disc herniation at the time of enrollment (Visit 1)
- •3.Patients on whom over 1 week have passed since the onset of lumbar disc herniation and are taking NSAIDs at the time of enrollment (Visit 1)
- •4.Patients aged 18 years or older at the time of obtaining informed consent
- •5.Patients who can correctly evaluate lower limb pain by distinguishing between low back pain and lower limb pain
- •6.Patients who can understand the procedure of this study, answer questions in Japanese appropriately in writing and by electromagnetic means (ePRO) without assistance, and give their own written consent on their own free will to participate in this study by writing or electromagnetic means (eConsent)
排除标准
- •1.Patients with a period of 3 months or more from the onset of lower limb pain to the time of enrollment (Visit 1)
- •2.Patients with muscle weakness (Manual Muscle Testing; MMT<=3)*
- •: tibialis anterior muscle (L4), extensor hallucis longus muscle (L5), gastrocnemius muscle (S1)
- •3.Patients with bladder and rectal disorders and scheduled for surgery during this study participation period
- •4.Patients with lower limb pain caused by disease other than lumbar disc herniation and considered difficult to be evaluated
- •5.Patients with severe pain caused by disease other than lumbar disc herniation and considered difficult to be evaluated
- •6.Patients scheduled for surgery that will affect the efficacy evaluation of lower limb pain caused by lumbar disc herniation
- •7.Patients with a history of lumbar spine surgery
- •8.Patients with creatinine clearance (CLcr) less than 30 mL/min
- •9.Patients with serious hepatic, renal, or cardiac disease
- •10.Patients who have taken prohibited concomitant medications within 7 days prior to enrollment (Visit 1)
- •11.Patients who have received prohibited concomitantly therapy within 7 days prior to enrollment (Visit 1)
- •12.Patients who have taken mirogabalin for lumbar disc herniation currently occurred
- •13.Patients taking mirogabalin for diseases other than lumbar disc herniation
- •14.Patients with a history of hypersensitivity to the ingredients of mirogabalin
- •15.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 are planning to become pregnant within 6 months after obtaining informed consent
- •16.Patients participating in or scheduled to participate in other intervention studies at the time of enrollment
- •17.Other patients judged by the principal investigator or subinvestigator to be unsuitable for participation in this study
结局指标
主要结局
Change in lower limb pain NRS
时间窗: from baseline to 1, 2, 4, and 8 weeks
Numerical Rating Scale; 11-point scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
次要结局
- Change in sleep disturbance NRS(baseline to 1, 2, 4, and 8 weeks)
- Change in low back pain NRS(baseline to 1, 2, 4, and 8 weeks)
- Change in Japanese Orthopaedic Association JOABPEQ score(baseline to 2 and 8 weeks)
- Time course of EQ-5D-5L score and health condition VAS(baseline to 2 and 8 weeks)
- Time course of Neuropathic Pain Symptom Inventory (NPSI) score(baseline to 2 and 8 weeks)
- Patient Global Impression of Change (PGIC)(8 weeks)
- Time to 30% improvement in lower limb pain NRS
- Area Under the Curve (AUC) of lower limb pain NRS
- 30% responder rate and 50% responder rate at week 8 for lower limb pain VAS(week 8)
研究者
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