Status:
COMPLETED
Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
Lead Sponsor:
Brown, Theodore R., M.D., MPH
Collaborating Sponsors:
Teva Neuroscience, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01454791
Start Date
January 1 2011
End Date
March 1 2013
Last Update
March 5 2015
Active Locations (1)
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1
MS Center at Evergreen Healthcare
Kirkland, Washington, United States, 98034