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

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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Glatiramer Glatiramer acetate

U.S. FDA Resources

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

Primary Outcome Measures:

Local injection site reaction (0-6) scale at Baseline, weeks 2, weeks 4 [ Time Frame: baseline, weeks 2, weeks 4 ] [ Designated as safety issue: No ]
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.
pain scale at weeks 2 and 4 [ Time Frame: weeks 2 and 4 ] [ Designated as safety issue: No ]
0-10 subjective Likert scale for severity of injection site reaction associated pain

Secondary Outcome Measures:

subject global impression at baseline, weeks 2, weeks 4 [ Time Frame: baseline, weeks 2 and 4 ] [ Designated as safety issue: No ]
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 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 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier:	NCT01454791 History of Changes
Other Study ID Numbers:	WIRB 20101775
Study First Received:	August 9, 2011
Last Updated:	March 20, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Brown, Theodore R., M.D., MPH:

multiple sclerosis
diclofenac
subcutaneous injection
glatiramer acetate
Copaxone

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Diclofenac
Copolymer 1
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 19, 2013