JPRN-jRCTs031200282已完成4 期
Clinical effect of NTN tablets on lumbar spinal canal stenosis with low back pain-Multicenter,Randomized,Active-control open-label trial
Eguchi Yawara0 个研究点目标入组 66 人开始时间: 2021年1月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
We exploratory investigated the improvement effects of NTN tablets, Limaprost tablets, and the combination of both drugs on low back pain, leg pain/numbness, and Gait-related activity in lumbar spinal canal stenosis patients with low back pain. There was no additional effect on lower limb pain in the combination group compared to single drug groups, but the additional effect on walking speed was suggested.
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
- •1) Patients who receive enough explanation about this study and sign written informed consents
- •2) Patients whose ages are over 20 years old
- •3) Patients who have low back pain
- •4) Patients with lumbar spinal canal stenosis checked with MRI
- •5) Patients with intermittent claudication
- •6) Patients who fill with the below conditions for clinical test results before the registration
- •(1) ALT is less than 2.5 times the upper limit of the normal range
- •(2) AST is less than 2.5 times the upper limit of the normal range
- •7) Patients who have not received the below drugs before obtaining consent
- •(1) Within 12 weeks before obtaining consent
- •a) An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus
- •b) Limaprost Alfadex
- •c) Study drug or other study drug under clinical study
- •(2) Within 7 days before obtaining consent
- •a) Prostaglandin formulation
排除标准
- •1) Patients with a surgical history of lumbar spinal tube
- •2) Suitable patients for surgery of lumbar spinal canal stenosis
- •3) Patients with spinal disc herniation
- •4) Patients with peripheral arterial occlusive disease
- •5) Patients who have or are suspected of peripheral neuropathy (diabetic, alcoholic and drug-induced etc.)
- •6) Patients with other gait disorders that have possible influence on effectiveness assessment, and patients who have pain and numbness in lumbar which are not caused by lumbar spinal canal stenosis
- •7) Patients who have nerve root block injections which may affect efficacy evaluation within 3 months before obtaining consent, or who plan to have the injection during the study period after obtaining consents
- •8) Patients with a history of hypersensitivity for An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus and Limaprost Alfadex
- •9) Patients who show symptoms associated with cerebropathy, cerebral infarction and cerebral hemorrhage, or have shown within 6 months after administration of study drugs
- •10) Patients who have or history of compilations of convulsive seizure or epileptic seizure
- •11) Patients who have severe respiratory diseases, cardiac diseases, kidney diseases, liver diseases and hematologic diseases
- •12) Patients who have mental disorder including depression, and who are judged to be significant danger by participating in the study, by a research representative physician or a research physician
- •13) Women who are pregnant, lactating, and pregnancy potential, or who hope to be pregnant during this study
- •14) Patients who take other study drugs and investigational agents within 12 weeks after starting study drugs administration
- •15) Others, patients who are judged as unsuitable for participating, by a research representative physician or a research physician
研究者
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