A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alcohol Wipes vs. No Alcohol Wipes
Sponsored by

About this trial
This is an interventional prevention trial for Multiple Sclerosis focused on measuring Copaxone
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
Outcomes
Primary Outcome Measures
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection
Secondary Outcome Measures
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection
Full Information
NCT ID
NCT00220922
First Posted
September 20, 2005
Last Updated
April 7, 2011
Sponsor
Teva Neuroscience, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00220922
Brief Title
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.
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®
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Teva Neuroscience, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Copaxone
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
Arm Title
2
Arm Type
Experimental
Arm Description
injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
Intervention Type
Procedure
Intervention Name(s)
Alcohol Wipes vs. No Alcohol Wipes
Other Intervention Name(s)
Copaxone
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MerriKay Oleen-Burkey, Ph.D.
Organizational Affiliation
Teva Neuroscience, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.
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