We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454791
First Posted: October 19, 2011
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Brown, Theodore R., M.D., MPH
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis Drug: diclofenac sodium topical gel Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Brown, Theodore R., M.D., MPH:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Voltaren gel
Other: Placebo
a placebo gel is applied 1-4 times per day for two weeks.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454791


Locations
United States, Washington
MS Center at Evergreen Healthcare
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Brown, Theodore R., M.D., MPH
Teva Neuroscience, Inc.
Investigators
Principal Investigator: Ted R Brown, MD, MPH MS Center at Evergreen Healthcare
  More Information

Responsible Party: Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier: NCT01454791     History of Changes
Other Study ID Numbers: WIRB 20101775
First Submitted: August 9, 2011
First Posted: October 19, 2011
Results First Submitted: July 22, 2014
Results First Posted: February 13, 2015
Last Update Posted: March 5, 2015
Last Verified: January 2015

Keywords provided by Brown, Theodore R., M.D., MPH:
multiple sclerosis
diclofenac
subcutaneous injection
glatiramer acetate
Copaxone

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Diclofenac
Glatiramer Acetate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents