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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol Wipes vs. No Alcohol Wipes

Procedure

Other names: Copaxone

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

Sponsors and collaborators

Lead sponsor

Teva Neuroscience, Inc.

Industry

Registry information

Official study title

An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2006
First posted: Sep 22, 2005
Registry last updated: Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed