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NCT00220922 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Official 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®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00220922
Other study ID # PM013
Secondary ID
Status Completed
Phase Phase 4
First received September 20, 2005
Last updated April 7, 2011
Start date August 2004
Est. completion date February 2006

Study information
Verified date April 2011
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 2006
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Alcohol Wipes vs. No Alcohol Wipes

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Teva Neuroscience, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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