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

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00220922

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Procedure: Alcohol Wipes vs. No Alcohol Wipes	Phase IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Ethanol Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study
Official Title:	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®

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	August 2004
Study Completion Date:	February 2006
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection	Procedure: Alcohol Wipes vs. No Alcohol Wipes
2: Experimental injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection	Procedure: Alcohol Wipes vs. No Alcohol Wipes

Detailed Description:

This is a randomized, single cross-over study with each subject using the two methods of injection site preparation during the study period.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220922

Locations

United States, Alabama
North Central Neurology
Cullman, Alabama, United States
United States, Florida
MS Comprehensive Care Center of Central Florida
Orlando, Florida, United States
United States, Georgia
Neurology & Headache Specialists of Atlanta
Decatur, Georgia, United States
United States, Kentucky
Louisville Comprehensive Care Multiple Sclerosis Center, LLC
Louisville, Kentucky, United States
United States, Texas
Integra Clinical Research, LLC
San Antonio, Texas, United States
United States, Virginia
Neurology Center of Fairfax, LTD
Fairfax, Virginia, United States

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

MerriKay Oleen-Burkey, Ph.D.

Teva Pharmaceutical Industries

More Information

Additional Information:

For more information on Multiple Sclerosis This link exits the ClinicalTrials.gov site

For more information about Teva Neuroscience, Inc. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Teva Neuroscience ( Thomas Smith, M.D., Vice President, Medical Affairs )
Study ID Numbers:	PM013
Study First Received:	September 20, 2005
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00220922 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:

Copaxone

Study placed in the following topic categories:

Autoimmune Diseases
Demyelinating Diseases
Immunologic Factors
Adjuvants, Immunologic
Central Nervous System Depressants
Sclerosis
Immunosuppressive Agents

Copolymer 1
Anti-Infective Agents, Local
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Central Nervous System Depressants
Sclerosis
Immunosuppressive Agents

Pharmacologic Actions
Copolymer 1
Anti-Infective Agents, Local
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Central Nervous System Agents
Autoimmune Diseases of the Nervous System
Ethanol

ClinicalTrials.gov processed this record on May 06, 2009