NCT02375633已完成3 期
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic 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
- 166
- 主要终点
- The change of 100 mm Pain VAS
研究概览
简要总结
A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.
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
- Triple (Participant, Care Provider, 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
- •More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
- •Class 1 or 2 back pain patients along Quebec Task Force Classification
- •Patients with pain at least 40mm test results at visit2
- •The voluntary or legal guardian 's written consent to participate in this clinical trial subjects
排除标准
- •Severe gastrointestinal disease, heart disease, high blood pressure patients
- •Patients with secondary causes are obvious
- •Within 24 weeks patient who has back surgery before clinical trial participation
- •Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
- •Within 4 weeks patient who treated steroid drug by oral or injection
- •Within 2 weeks patient who treated MAO inhibition drugs
- •Patients with severe respiratory depression status
研究组 & 干预措施
DW-330SR2
Experimental
DW-330SR(Pelubiprofen) 45mg twice a day
干预措施: DW-330SR2 (Drug)
Pelubiprofen
Active Comparator
Active Comparator(Pelubiprofen) 30mg three times a day
干预措施: Pelubiprofen (Drug)
结局指标
主要结局
The change of 100 mm Pain VAS
时间窗: 28 days
次要结局
未报告次要终点
研究者
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