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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: diclofenac sodium topical gel; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • MS Center at Evergreen Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Sodium Topical Gel first then Placebo; 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).	Drug: diclofenac sodium topical gel; diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo; Other Names: Voltaren gel; Other: Placebo; a placebo gel is applied 1-4 times per day for two weeks.
Placebo Comparator: Placebo first then Diclofenac Sodium Topical Gel; 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).	Drug: diclofenac sodium topical gel; diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo; Other Names: Voltaren gel; Other: Placebo; a placebo gel is applied 1-4 times per day for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks	patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.	2 weeks
Pain Scale at 2 Weeks	0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Global Impression at 2 Weeks	This is a single question: "How would you rate your level of comfort with Copaxone injection during the past two weeks?" Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad.	2 weeks

Collaborators and Investigators

• Sponsor: Brown, Theodore R., M.D., MPH
• Collaborators: Teva Neuroscience, Inc.
• Investigators: Principal Investigator: Ted R Brown, MD, MPH, MS Center at Evergreen Healthcare

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: multiple sclerosis; diclofenac; subcutaneous injection; glatiramer acetate; Copaxone
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: WIRB 20101775

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No