JPRN-jRCTs061220102招募中4 期
Exploratory study of Efficacy and Safety for Mirogabalin Treatment as Add-On to NSAIDs with Neuropathic Pain patients caused by Lumbar Disc Herniation
Suzuki Hidenori0 个研究点目标入组 180 人开始时间: 2023年2月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients diagnosed with lumbar disc herniation by MRI imaging findings by the time of enrollment (Visit 1)
- •2. 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
研究者
相似试验
招募中
4 期
Miro-Canpeuropathic cancer painJPRN-jRCTs031220569Hashiguchi Saori140
尚未招募
不适用
Examination of efficacy and safety treated by Mirogabalin in patients with peripheral neuropathy in Orthopaedic diseasePatients with peripheral neuropathy in Orthopaedic diseasesJPRN-UMIN000037150Dept. of Orthopaedic Surgery Shinshu University School of Medicine60
尚未招募
4 期
A comparative effects of Dermaroller with Triamcinolone Acetonide v/s Dermaroller with platelet rich plasma v/s Dermaroller alone in treatment of patchy hair lossCTRI/2020/02/023471MGM Medical College and Hospital Aurangabad
尚未招募
不适用
Evaluation of safety and effectiveness of the Microwave Surgical Device (Acrosurg.TM) in surgical procedures.Disease for Digestive surgery (esophagus, stomach, colorectum, pancreas, liver and hernia) and Breast surgery.JPRN-UMIN000023758Shiga University of Medical Science Department of Surgery40
招募中
4 期
Type II Diabetic STUDYCTRI/2016/01/006486SV Limited270