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

Phase 4

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT00220922
• Lead Sponsor: Teva Neuroscience, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2005-10
• Study Completion: 2006-02
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection	four weeks of Period 1 and the four weeks of Period 2

Secondary Outcome Measures

Name	Time	Method
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection	four weeks of Period 1 and the four weeks of Period 2