A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

February 2, 2017 updated by: Teva Neuroscience, Inc.

An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.

This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States
        • Fullerton Neurology & Headache Center
    • Florida
      • Miami, Florida, United States
        • Neurological Center of South Florida
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Springfield Neurology Associates
    • New York
      • Brooklyn, New York, United States
        • Multiple Sclerosis Care Center
    • Tennessee
      • Nashville, Tennessee, United States
        • Advanced Neurosciences Institute
    • Virginia
      • Virginia Beach, Virginia, United States
        • Virginia Beach Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or Female, 18 years or older, with a diagnosis of RRMS
  2. Willing and able to complete all procedures and evaluations related to the study.
  3. Willing to provide Informed Consent

Exclusion Criteria:

  1. Taking any other immunomodulatory therapy in conjunction with Copaxone®.
  2. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
  3. Any situation which the investigator or nurse feels may interfere with participation in the study.
  4. Pregnant, or trying to become pregnant, or breast feeding during the study.
  5. Previously participated in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
skin reactions with the use of warm compress prior to performing a Copaxone® injection
Drug: glatiramer acetate
Other Names:
  • Copaxone
Experimental: 2
skin reactions without the use of warm compress prior to performing a Copaxone® injection
Procedure: Warm compress prior to injection of glatiramer acetate
Other Names:
  • Copaxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection
Time Frame: 2-week diaries kept by the patients for Period 1 and for Period 2
2-week diaries kept by the patients for Period 1 and for Period 2

Secondary Outcome Measures

Outcome Measure
Time Frame
The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection
Time Frame: 2-week diaries kept by the patients for Period 1 and for Period 2
2-week diaries kept by the patients for Period 1 and for Period 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Neuroscience, Inc.

Investigators

  • Study Director: MerriKay Oleen-Burkey, Ph.D, Teva Neuroscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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