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

NCT ID: NCT00220922

Last Updated: 2011-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection

Group Type EXPERIMENTAL

Alcohol Wipes vs. No Alcohol Wipes

Intervention Type PROCEDURE

2

injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection

Group Type EXPERIMENTAL

Alcohol Wipes vs. No Alcohol Wipes

Intervention Type PROCEDURE

Interventions

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Alcohol Wipes vs. No Alcohol Wipes

Intervention Type PROCEDURE

Other Intervention Names

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Copaxone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Neuroscience

Principal Investigators

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MerriKay Oleen-Burkey, Ph.D.

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Other Identifiers

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PM013

Identifier Type: -

Identifier Source: org_study_id

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