Conditions: Multiple Sclerosis
Keywords: multiple sclerosis diclofenac subcutaneous injection glatiramer acetate Copaxone
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). arm 2: 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

Interventions: intervention 1: diclofenac sodium topical gel intervention 2: Placebo
Intervention descriptions: intervention 1: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo intervention 2: a placebo gel is applied 1-4 times per day for two weeks.

Protocol document: