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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown, Theodore R., M.D., MPH
• Collaborator: Teva Neuroscience, Inc.
• Treatments: Diclofenac; Glatiramer Acetate

Criteria

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.