A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00239993
First received: September 22, 2005
Last updated: April 16, 2009
Last verified: April 2009
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Purpose
This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: glatiramer acetate Procedure: Warm compress prior to injection of glatiramer acetate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| 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®. |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- The number of local injection site reactions (LISRs) noted at 5-minutes post-injection [ Time Frame: 2-week diaries kept by the patients for Period 1 and for Period 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection [ Time Frame: 2-week diaries kept by the patients for Period 1 and for Period 2 ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | August 2005 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
skin reactions with the use of warm compress prior to performing a Copaxone® injection
|
Drug: glatiramer acetate
Other Name: Copaxone
|
|
Experimental: 2
skin reactions without the use of warm compress prior to performing a Copaxone® injection
|
Procedure: Warm compress prior to injection of glatiramer acetate
Other Name: Copaxone
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or Female, 18 years or older, with a diagnosis of RRMS
- Willing and able to complete all procedures and evaluations related to the study.
- Willing to provide Informed Consent
Exclusion Criteria:
- Taking any other immunomodulatory therapy in conjunction with Copaxone®.
- 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.
- Any situation which the investigator or nurse feels may interfere with participation in the study.
- Pregnant, or trying to become pregnant, or breast feeding during the study.
- Previously participated in this study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239993
Locations
| United States, California | |
| Fullerton Neurology & Headache Center | |
| Fullerton, California, United States | |
| United States, Florida | |
| Neurological Center of South Florida | |
| Miami, Florida, United States | |
| United States, Massachusetts | |
| Springfield Neurology Associates | |
| Springfield, Massachusetts, United States | |
| United States, New York | |
| Multiple Sclerosis Care Center | |
| Brooklyn, New York, United States | |
| United States, Tennessee | |
| Advanced Neurosciences Institute | |
| Nashville, Tennessee, United States | |
| United States, Virginia | |
| Virginia Beach Neurology | |
| Virginia Beach, Virginia, United States | |
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
| Study Director: | MerriKay Oleen-Burkey, Ph.D | Teva Neuroscience, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience |
| ClinicalTrials.gov Identifier: | NCT00239993 History of Changes |
| Other Study ID Numbers: | PM016 |
| Study First Received: | September 22, 2005 |
| Last Updated: | April 16, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Copolymer 1 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013