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

Condition(s) targeted: Multiple Sclerosis

Intervention: diclofenac sodium topical gel (Drug); Placebo (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Brown, Theodore R., M.D., MPH

Official(s) and/or principal investigator(s):
Ted R Brown, MD, MPH, Principal Investigator, Affiliation: MS Center at Evergreen Healthcare

Overall contact:
Ted Brown, MD, MPH, Phone: 425-899-5365, Email: trbrown@evergreenhealthcare.org

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.

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome:

Local injection site reaction (0-6) scale at Baseline, weeks 2, weeks 4

pain scale at weeks 2 and 4

Secondary outcome: subject global impression at baseline, weeks 2, weeks 4

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 receive instruction on how to apply the DSTG/placebo at the injection site and keep a daily injection site reaction diary.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Ted Brown, MD, MPH, Phone: 425-899-5365, Email: trbrown@evergreenhealthcare.org

MS Center at Evergreen Healthcare, Kirkland, Washington 98034, United States; Recruiting
Carey L Gonzales, Coordinator, Phone: 425-899-5374, Email: clgonzales@evergreenhealth.com
Shalom Kilcup, Coordinator, Phone: 425-899-5369, Email: sekilcup@evergreenhealth.com
Ted Brown, MD., MPH, Principal Investigator
Lahar Mehta, MD, Sub-Investigator

Starting date: January 2011
Last updated: December 13, 2012