Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: diclofenac sodium topical gel
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac Sodium Topical Gel first then Placebo<br>1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). | Drug: diclofenac sodium topical gel<br>* diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo<br>* Other names: Voltaren gel;Other: Placebo<br>* a placebo gel is applied 1-4 times per day for two weeks.<br>|
| Placebo Comparator: Placebo first then Diclofenac Sodium Topical Gel<br>1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). | Drug: diclofenac sodium topical gel<br>* diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo<br>* Other names: Voltaren gel;Other: Placebo<br>* a placebo gel is applied 1-4 times per day for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, diclofenac, subcutaneous injection, glatiramer acetate, Copaxone