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
- Interventions
- Procedure: Alcohol Wipes vs. No Alcohol Wipes
- 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
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
- Arm && Interventions
Group Intervention Description 1 Alcohol Wipes vs. No Alcohol Wipes injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection 2 Alcohol Wipes vs. No Alcohol Wipes injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
- 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