Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | January 2011 |
| End Date: | April 2013 |
| Contact: | Ted Brown, MD, MPH |
| Email: | trbrown@evergreenhealthcare.org |
| Phone: | 425-899-5365 |
Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial
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.
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.
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