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

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.

Timeline

Start

2011-01

Primary completion

2013-03

Completion

2013-03

Outcome

Missed primary endpoint

registry Diclofenac Sodium Topical Gel vs Placebo; p = 0.45; Mean Difference (Final Values) -0.08; t-test, 2 sided NCT01454791 ↗

registry Diclofenac Sodium Topical Gel vs Placebo; p = 0.6059; Mean Difference (Final Values) -0.16; t-test, 2 sided NCT01454791 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	1 %	Topical

Indications