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Completed

NCT Number: NCT01454791

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MS Center at Evergreen Healthcare

Kirkland, Washington, 98034, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac Sodium Topical Gel

Drug

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

Placebo

Other

a placebo gel is applied 1-4 times per day for two weeks.

Primary outcomes

  1. Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks

    Time frame: 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. Pain Scale at 2 Weeks

    Time frame: 2 weeks

    0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst

Secondary outcomes

  1. Subject Global Impression at 2 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown, Theodore R., M.D., MPH

Indiv

Collaborators

  • Teva Neuroscience, Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2011
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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