NCT00239993已完成4 期
An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.
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
- 50
- 试验地点
- 6
- 主要终点
- The 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 skin reactions with or without the use of warm compress prior to performing a 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, 18 years or older, with a diagnosis of RRMS
- •Willing and able to complete all procedures and evaluations related to the study.
- •Willing to provide Informed Consent
排除标准
- •Taking any other immunomodulatory therapy in conjunction with Copaxone®.
- •Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
- •Any situation which the investigator or nurse feels may interfere with participation in the study.
- •Pregnant, or trying to become pregnant, or breast feeding during the study.
- •Previously participated in this study.
研究组 & 干预措施
1
Experimental
skin reactions with the use of warm compress prior to performing a Copaxone® injection
干预措施: glatiramer acetate (Drug)
2
Experimental
skin reactions without the use of warm compress prior to performing a Copaxone® injection
干预措施: Warm compress prior to injection of glatiramer acetate (Procedure)
结局指标
主要结局
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection
时间窗: 2-week diaries kept by the patients for Period 1 and for Period 2
次要结局
- The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection(2-week diaries kept by the patients for Period 1 and for Period 2)
研究者
研究点 (6)
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