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

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

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: diclofenac sodium topical gel; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01454791

WIRB 20101775

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Diclofenac Sodium Topical Gel first then Placebo

Experimental group

Description:

1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

Treatment:

Other: Placebo

Drug: diclofenac sodium topical gel

Placebo first then Diclofenac Sodium Topical Gel

Placebo Comparator group

Description:

1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

Treatment:

Other: Placebo

Drug: diclofenac sodium topical gel