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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
Teva Neuroscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Copaxone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    September 20, 2005
    Last Updated
    April 7, 2011
    Sponsor
    Teva Neuroscience, Inc.
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    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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