NCT01768468已完成4 期
Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
PMG Pharm Co., Ltd6 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- Change in 100mm Pain VAS
研究概览
简要总结
This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥40 and ≤ 80years of age
- •Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren & Lawrene radiographic entry criteria
- •Stable osteoarthritis during 3 months
- •Score of 100mm pain VAS ≤ 80mm at screening
- •Score of 100mm pain VAS ≥ 50mm at baseline
- •Written consent form voluntarily
排除标准
- •Disease of spine or other Lower limb joints that could affect to evaluate the efficacy
- •History of surgery or arthroscopy of the study joint within 6 months
- •Trauma of study joint within 12 months
- •Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
- •Medication of intra-articular injection within 3 months
- •Diagnosed with psychical disorder, and taking medication
- •History of upper gastrointestinal ulceration within 6 months
- •History of upper gastrointestinal bleeding within 12 months
- •Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test
- •History of hypersensitivity to LAYLA, JOINS, or NSAIDs
- •Participation in another clinical trials within 4 weeks
- •Medication of constantly (more than 1 week) narcotic analgesics within 3 months
- •Not consent about using effectual contraception method during trial
- •Pregnant or lactating woman
- •Investigator's judgment
研究组 & 干预措施
LAYLA
Experimental
Drug : LAYLA tablet/ bid
干预措施: LAYLA tablet (Drug)
JOINS
Active Comparator
Drug : JOINS tablet/ tid
干预措施: JOINS tablet (Drug)
结局指标
主要结局
Change in 100mm Pain VAS
时间窗: baseline throgh week 8
次要结局
- Change from baseline in 100mm pain VAS(12 weeks)
- Change rate from baseline in 100mm Pain VAS(8 weeks, 12 weeks)
- Change from baseline in WOMAC(8 weeks, 12 weeks)
- Change from baseline in EQ-5D(8 weeks, 12 weeks)
- Consumption of rescue medication(4 times)
- Change in the patient self-assessed & investigator-assessed overall symptom score(8 weeks, 12 weeks)
研究者
研究点 (6)
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