NCT01776515已完成1 期
A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- Changes in '100 mm pain VAS' value from baseline
研究概览
简要总结
The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 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 20 years
- •Patient with low back pain who needs analgesic administration
- •Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification
- •Pain VAS Value over 40 mm
- •Subjects who voluntarily or legal guardian agreed with written consent
排除标准
- •Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension
- •Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease)
- •Patients who had taken back surgery within 24 weeks from the screening point
- •Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point
- •Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point
研究组 & 干预措施
Tramadol hydrochloride/Acetaminophen Tab.
Active Comparator
干预措施: Tramadol hydrochloride/Acetaminophen Tab. (Drug)
Tramadol hydrochloride/Acetaminophen SR Tab.
Experimental
干预措施: Tramadol hydrochloride/Acetaminophen SR Tab. (Drug)
结局指标
主要结局
Changes in '100 mm pain VAS' value from baseline
时间窗: 0, 1, 7, 14, 28 day
次要结局
未报告次要终点
研究者
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