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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

diclofenac sodium topical gel

Intervention Type 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

Placebo

Intervention Type OTHER

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

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).

Group Type PLACEBO_COMPARATOR

diclofenac sodium topical gel

Intervention Type 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

Placebo

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Voltaren gel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No