Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
研究概览
简要总结
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 - 65 years of age;
- •Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis;
- •Currently being treated with Avonex® for at least 90 days;
- •Using 25 gauge needles for injection of Avonex® for at least 90 days;
- •Willing and able to complete study questionnaires; and
- •Provided informed consent to participate in this study
排除标准
- •Diagnosis of Progressive Multiple Sclerosis;
- •History of recent illness or infection;
- •History of allergic reaction to Avonex®;
- •Any prior usage of a 30 gauge needle for administration of Avonex®;
- •Concurrent treatment with other immunomodulating therapies;
- •Pregnant or planning on becoming pregnant;
- •Nursing mothers; and
- •Unable to complete the requirements of the study
研究组 & 干预措施
30 gauge
Subjects used a 30 gauge needle for intramuscular injection of Avonex.
干预措施: Avonex (Drug)
25 gauge
Subjects used a 25 gauge needle for intramuscular injection of Avonex.
干预措施: Avonex (Drug)
结局指标
主要结局
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
时间窗: Weeks 2, 3, 4, 5
The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.
Visual Analog Scale Score for Post-injection Pain
时间窗: Weeks 2, 3, 4, 5
The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.
次要结局
- Fear of Injection(Weeks 2, 3, 4, 5)
- Perception of Needle(Weeks 2, 3, 4, 5)