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NCT00239993 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Official title:
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®.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00239993
Other study ID # PM016
Secondary ID
Status Completed
Phase Phase 4
First received September 22, 2005
Last updated February 2, 2017
Start date August 2005
Est. completion date February 2006

Study information
Verified date February 2017
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 2006
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• glatiramer acetate

Procedure:
• Warm compress prior to injection of glatiramer acetate

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

Sponsors (1)
Lead Sponsor Collaborator
Teva Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of local injection site reactions (LISRs) noted at 5-minutes post-injection 2-week diaries kept by the patients for Period 1 and for Period 2
Secondary The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection 2-week diaries kept by the patients for Period 1 and for Period 2
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