NCT02064634Unknown不适用
A Multicenter, Comparative, Open Label, Prospective Observational Study on Discontinuation of Medication Due to Gastrointestinal Adverse Effects for the Patients Being Treated for Osteoarthritis With Anti-inflammatory Analgesic Drug
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 6,700
- 试验地点
- 1
- 主要终点
- Discontinuation rate due to gastrointestinal adverse effects
研究概览
简要总结
This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Minimum 20- year-old patients diagnosed with osteoarthritis
- •Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs)
- •Written consent form voluntarity
排除标准
- •Diagnosed with disease that may affect measurement of efficacy clinically
- •Diagnosed with clinically significant phycological disorder, and taking medication
- •Participated in a clinical trial within 4 weeks
- •Pregnant or lactating woman
- •History of malignant disease within the previous 5 years
- •Patients who seem not to participate in the study at investigator's discretion
结局指标
主要结局
Discontinuation rate due to gastrointestinal adverse effects
时间窗: up to 12 weeks
次要结局
- Rate of medication discontinuation recorded as lack of efficacy(up to 12 weeks)
- Rate of medication discontinuation(up to 12 weeks)
- Discontinuation rate due to adverse events(up to 12 weeks)
研究者
研究点 (1)
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