NCT01604239已完成4 期
A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 761
- 试验地点
- 18
- 主要终点
- Percentage of subjects with gastrointestinal adverse events
研究概览
简要总结
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 19 years old
- •Kellgren stage I ~ III by ACR criteria
- •Stable osteoarthritis during 3 months
- •Be able to perform WOMAC and KKS
- •Written consent form voluntarily
排除标准
- •Disease of orthopaedic surgical that could affect to evaluate the efficacy
- •Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
- •Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
- •Medical history of hypersensitivity reaction against Herbal drug
- •Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
- •Occurrence of OA caused by the injury
- •Diagnosed with psychical disorder, and taking medication
- •Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
- •Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
- •Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
- •Positive in fecal occult blood test
- •Gastrointestinal tract surgery except appendectomy
- •Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
- •Participation in another clinical trials within 4 weeks
- •Not consent about using effectual contraception method during trial
- •Pregnant or lactating woman
- •Medical history of malignant tumor within 5 years
- •Investigator's judgment
研究组 & 干预措施
Shinbaro
Experimental
干预措施: Shinbaro Capsule (Drug)
结局指标
主要结局
Percentage of subjects with gastrointestinal adverse events
时间窗: Baseline through 24 weeks
次要结局
- Frequency of AEs(baseline throgh week 24)
- WOMAC change from baseline(24 weeks)
- percentage of subjects with perforation, ulcer, bleeding(baseline throgh week 24)
- percentage of subjects who withdrew due to GI AEs(baseline through week 24)
- KKS (Korean Knee Score) change from baseline(24 weeks)
- 100mm pain VAS on walking(24 weeks)
研究者
研究点 (18)
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