Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
研究概览
简要总结
The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on injection site reaction following self-administer glatiramer acetate in people with Multiple Sclerosis.
详细描述
A 4 week study with active or placebo medication at randomization and switch treatment at 2-week crossover visit (2 weeks on each arm). There will be a total of 3 visits to the clinic. Subjects will receive instruction on how to apply the DSTG/placebo at the injection site and keep a daily injection site reaction diary.
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
- Double (Participant, 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
- •Diagnosis of Multiple Sclerosis (MS) made at least 3 months prior based on McDonald or Poser criteria.
- •Age 18 or more
- •Ongoing treatment with glatiramer acetate (Copaxone) for three months or more.
- •No MS exacerbation for 60 days prior to screening.
- •Mean score of greater than or equal to 1.0 on screening Local Injection Site Reaction scale of last 3 days.
- •Written informed consent.
排除标准
- •Regular use of any non-steroidal anti-inflammatory drug (NDAID), except Asprin (<325 mg daily), between screening and end of study.
- •Any contraindication to Diclofenac Sodium Topical Gel (DSTG)
- •allergy to DSTG or any NSAID.
- •history of asthma, urticaria, or other allergic reaction after taking any NSAID.
- •Females who are breast feeding, pregnant or have potential to become pregnant during the course of the study(fertile and unwilling/unable to use effective contraceptive measures).
- •Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing.
- •Any other serious and/or unstable medical condition.
研究组 & 干预措施
Diclofenac Sodium Topical Gel first then Placebo
1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).
干预措施: diclofenac sodium topical gel (Drug)
Diclofenac Sodium Topical Gel first then Placebo
1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).
干预措施: Placebo (Other)
Placebo first then Diclofenac Sodium Topical Gel
1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).
干预措施: diclofenac sodium topical gel (Drug)
Placebo first then Diclofenac Sodium Topical Gel
1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).
干预措施: Placebo (Other)
结局指标
主要结局
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
时间窗: 2 weeks
patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.
Pain Scale at 2 Weeks
时间窗: 2 weeks
0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst
次要结局
- Subject Global Impression at 2 Weeks(2 weeks)