A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

Phase 4CompletedNCT00220922

Teva Neuroscience, Inc.50 enrolled

Overview

This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Alcohol Wipes vs. No Alcohol WipesPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female * 18 years of age or older * Diagnosis of RRMS * Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously Exclusion Criteria: * Unable to perform subcutaneous self-injection * Pregnant, or trying to become pregnant, or breast feeding during the study

Outcomes

Primary Outcomes

Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection

Time frame: four weeks of Period 1 and the four weeks of Period 2

Secondary Outcomes

The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection

Time frame: four weeks of Period 1 and the four weeks of Period 2

Data from ClinicalTrials.gov

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