NCT01454791

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

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Brown, Theodore R., M.D., MPH · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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	Placebo	a placebo gel is applied 1-4 times per day for two weeks.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-10-19
• Last updated: 2015-03-05
• Results posted: 2015-02-13

Locations

1 site across 1 country: United States