NCT00220922已完成4 期
An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection
研究概览
简要总结
This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Male or Female
- •18 years of age or older
- •Diagnosis of RRMS
- •Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously
排除标准
- •Unable to perform subcutaneous self-injection
- •Pregnant, or trying to become pregnant, or breast feeding during the study
结局指标
主要结局
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection
时间窗: four weeks of Period 1 and the four weeks of Period 2
次要结局
- The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection(four weeks of Period 1 and the four weeks of Period 2)
研究者
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