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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00220922 |
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 |
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® |
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 |
This is a randomized, single cross-over study with each subject using the two methods of injection site preparation during the study period.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | MerriKay Oleen-Burkey, Ph.D. | Teva Pharmaceutical Industries |
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 |
Copaxone |
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 |
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 |