Back to resultsA Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
glatiramer acetate
Warm compress prior to injection of glatiramer acetate
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis
Eligibility 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.
Sites / Locations
- Fullerton Neurology & Headache Center
- Neurological Center of South Florida
- Springfield Neurology Associates
- Multiple Sclerosis Care Center
- Advanced Neurosciences Institute
- Virginia Beach Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
skin reactions with the use of warm compress prior to performing a Copaxone® injection
skin reactions without the use of warm compress prior to performing a Copaxone® injection
Outcomes
Primary Outcome Measures
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection
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
Full Information
NCT ID
NCT00239993
First Posted
September 22, 2005
Last Updated
February 2, 2017
Sponsor
Teva Neuroscience, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00239993
Brief Title
A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Teva Neuroscience, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
skin reactions with the use of warm compress prior to performing a Copaxone® injection
Arm Title
2
Arm Type
Experimental
Arm Description
skin reactions without the use of warm compress prior to performing a Copaxone® injection
Intervention Type
Drug
Intervention Name(s)
glatiramer acetate
Other Intervention Name(s)
Copaxone
Intervention Type
Procedure
Intervention Name(s)
Warm compress prior to injection of glatiramer acetate
Other Intervention Name(s)
Copaxone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MerriKay Oleen-Burkey, Ph.D
Organizational Affiliation
Teva Neuroscience, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Fullerton Neurology & Headache Center
City
Fullerton
State/Province
California
Country
United States
Facility Name
Neurological Center of South Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
Springfield Neurology Associates
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Multiple Sclerosis Care Center
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Virginia Beach Neurology
City
Virginia Beach
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
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