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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00239993
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : February 6, 2017
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: glatiramer acetate Procedure: Warm compress prior to injection of glatiramer acetate Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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®.
Study Start Date : August 2005
Primary Completion Date : December 2005
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Neuroscience, Inc.
Investigators
Study Director: MerriKay Oleen-Burkey, Ph.D Teva Neuroscience, Inc.
More Information

Additional Information:
Responsible Party: Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00239993     History of Changes
Other Study ID Numbers: PM016
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents