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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00239993
First received: September 22, 2005
Last updated: April 16, 2009
Last verified: April 2009
  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:


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014