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

Completed · Phase 4 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT01454791
Run by: Brown, Theodore R., M.D., MPH
People needed: 40
Starts: 2011-01-01
Expected to finish: 2013-03-01
Last updated by the study team: 2015-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

MS Center at Evergreen Healthcare — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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