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

April 7, 2011 updated by: Teva Neuroscience, Inc.

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®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
Procedure: Alcohol Wipes vs. No Alcohol Wipes
Other Names:
  • Copaxone
Experimental: 2
injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection
Procedure: Alcohol Wipes vs. No Alcohol Wipes
Other Names:
  • Copaxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
four weeks of Period 1 and the four weeks of Period 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
four weeks of Period 1 and the four weeks of 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, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM013

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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