NCT00240032已完成4 期
A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.
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
- 80
- 主要终点
- Injection Site Reaction
研究概览
简要总结
This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.
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
- Triple (Participant, Care Provider, Investigator)
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 < 3months) began self-injecting Copaxone®
排除标准
- •Taking any other immunomodulatory therapy in conjunction with Copaxone®
- •Unable to perform subcutaneous self-injection
- •Pregnant or trying to become pregnant, or breast feeding during the study
- •Previously participated in this study or in another clinical trial in the past 30 days
研究组 & 干预措施
Copaxone® with Zyrtec
Active Comparator
干预措施: glatiramer acetate injection with oral cetirizine hydrochloride (Drug)
Copaxone® with placebo
Experimental
干预措施: glatiramer acetate with placebo (Drug)
结局指标
主要结局
Injection Site Reaction
时间窗: 5 weeks
Injection site reaction after taking antihistamine
次要结局
未报告次要终点
研究者
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