NCT02040415已完成3 期
A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase Lll Clinical Trial to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 主要终点
- Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration
研究概览
简要总结
The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males/Females aged over 18 years
- •Patients with symptom of Acute skeletomuscle myospasm and Back pain
- •Patients with Pain VAS Value over 40 mm in Visit 2
- •Subjects who voluntarily or legal guardian agreed with written consent
排除标准
- •Patients with Back pain caused by spinal spondylosis, spinal stenosis, fractures, cancer, severe arthritis, osteoporosis, sciatica, infection
- •Muscular patients such as myositis, muscular atrophy disease, increased muscle tone, myasthenia gravis
- •Patients who had taken invasive procedures such as epidural injections or spinal stimulation to cure the back pain within 6 months from the screening point
- •Patients who had taken passive physical therapy or ionphoresis within 12 hours from the screening point
- •Patients with severe GI tract disorder, heart disease, hypertension
- •Patients who had taken NSAIDS within 24hours from the screening point
研究组 & 干预措施
DW-1030(eperisone HCl)
Experimental
DW-1030(eperisone HCl) 75mg BID
干预措施: DW-1030(eperisone HCl) 75mg (Drug)
DW-1030(eperisone HCl)
Experimental
DW-1030(eperisone HCl) 75mg BID
干预措施: Placebo drug of Myonal Tab. (Drug)
Myonal Tab.(eperisone HCl)
Active Comparator
Myonal Tab.(eperisone HCl) 50mg TID
干预措施: Myonal Tab.(eperisone HCl) 50mg (Drug)
Myonal Tab.(eperisone HCl)
Active Comparator
Myonal Tab.(eperisone HCl) 50mg TID
干预措施: Placebo drug of DW-1030 (Drug)
结局指标
主要结局
Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration
时间窗: 1, 3, 7 day
次要结局
- Changes of 100mm Pain VAS(-3, 1, 3, 7 day)
- Oswestry Disability Index (ODI)(1, 3, 7 day)
- The number of using rescue drugs and the total amount(1, 3, 7 days)
- Physician's Global Assessment(7 day)
研究者
相似试验
已完成
3 期
Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter PyloriHelicobacter Pylori Infected PatientsHelicobacter Pylori Infected SubjectsHelicobacter Pylori InfectionNCT06751121Daewoong Pharmaceutical Co. LTD.461
Unknown
不适用
Treatment Effect According to Timing of Administration of DWP14012 40 mgErosive EsophagitisNCT04888819Konkuk University Medical Center186
Unknown
不适用
Treatment Effect According to Timing of Administration of DWP14012 40 mgErosive EsophagitisNCT04613895Daewoong Pharmaceutical Co. LTD.186
已完成
3 期
BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine CombinationEssential HypertensionNCT03991442Boryung Pharmaceutical Co., Ltd257
已完成
3 期
The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes MellitusT2DM (Type 2 Diabetes Mellitus)NCT04654390Daewoong Pharmaceutical Co. LTD.270