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

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Procedure: Alcohol Wipes vs. No Alcohol Wipes

Study type: Interventional

Funder types: Industry

Identifiers

NCT00220922

PM013

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection

Treatment:

Procedure: Alcohol Wipes vs. No Alcohol Wipes

2

Experimental group

Description:

injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection

Treatment:

Procedure: Alcohol Wipes vs. No Alcohol Wipes