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

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

2005-08-31

Study Completion Date

2006-02-28

Brief Summary

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

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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

skin reactions with the use of warm compress prior to performing a Copaxone® injection

Group Type EXPERIMENTAL

glatiramer acetate

Intervention Type DRUG

2

skin reactions without the use of warm compress prior to performing a Copaxone® injection

Group Type EXPERIMENTAL

Warm compress prior to injection of glatiramer acetate

Intervention Type PROCEDURE

Interventions

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glatiramer acetate

Intervention Type DRUG

Warm compress prior to injection of glatiramer acetate

Intervention Type PROCEDURE

Other Intervention Names

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Copaxone Copaxone

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No