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A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
glatiramer acetate injection with oral cetirizine hydrochloride
glatiramer acetate with placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

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 < 3months) began self-injecting Copaxone® Exclusion Criteria: Taking any other immunomodulatory therapy in conjunction with Copaxone® Unable to perform subcutaneous self-injection Pregnant or trying to become pregnant, or breast feeding during the study Previously participated in this study or in another clinical trial in the past 30 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Copaxone® with Zyrtec

    Copaxone® with placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Injection Site Reaction
    Injection site reaction after taking antihistamine

    Secondary Outcome Measures

    Full Information

    First Posted
    October 13, 2005
    Last Updated
    April 7, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00240032
    Brief Title
    A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.
    Official Title
    A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Copaxone® with Zyrtec
    Arm Type
    Active Comparator
    Arm Title
    Copaxone® with placebo
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    glatiramer acetate injection with oral cetirizine hydrochloride
    Other Intervention Name(s)
    Copaxone®, Zyrtec®
    Intervention Description
    Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
    Intervention Type
    Drug
    Intervention Name(s)
    glatiramer acetate with placebo
    Other Intervention Name(s)
    Copaxone®
    Intervention Description
    Copaxone® injection 20 mg, oral placebo
    Primary Outcome Measure Information:
    Title
    Injection Site Reaction
    Description
    Injection site reaction after taking antihistamine
    Time Frame
    5 weeks

    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 < 3months) began self-injecting Copaxone® Exclusion Criteria: Taking any other immunomodulatory therapy in conjunction with Copaxone® Unable to perform subcutaneous self-injection Pregnant or trying to become pregnant, or breast feeding during the study Previously participated in this study or in another clinical trial in the past 30 days
    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 Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

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