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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
40
diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo
a placebo gel is applied 1-4 times per day for two weeks.
MS Center at Evergreen Healthcare
Kirkland, Washington, United States
Local Injection Site Reaction (0-6) Scale at Baseline, 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.
Time frame: 2 weeks
Pain Scale at 2 Weeks
0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst
Time frame: 2 weeks
Subject Global Impression at 2 Weeks
This is a single question: "How would you rate your level of comfort with Copaxone injection during the past two weeks?" Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad.
Time frame: 2 weeks
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