Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT00239993
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2005-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2005-09-22', 'studyFirstSubmitQcDate': '2005-10-13', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of local injection site reactions (LISRs) noted at 5-minutes post-injection', 'timeFrame': '2-week diaries kept by the patients for Period 1 and for Period 2'}], 'secondaryOutcomes': [{'measure': 'The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection', 'timeFrame': '2-week diaries kept by the patients for Period 1 and for Period 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or Female, 18 years or older, with a diagnosis of RRMS\n2. Willing and able to complete all procedures and evaluations related to the study.\n3. Willing to provide Informed Consent\n\nExclusion Criteria:\n\n1. Taking any other immunomodulatory therapy in conjunction with Copaxone®.\n2. 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.\n3. Any situation which the investigator or nurse feels may interfere with participation in the study.\n4. Pregnant, or trying to become pregnant, or breast feeding during the study.\n5. Previously participated in this study."}, 'identificationModule': {'nctId': 'NCT00239993', 'briefTitle': 'A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': '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®.', 'orgStudyIdInfo': {'id': 'PM016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'skin reactions with the use of warm compress prior to performing a Copaxone® injection', 'interventionNames': ['Drug: glatiramer acetate']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'skin reactions without the use of warm compress prior to performing a Copaxone® injection', 'interventionNames': ['Procedure: Warm compress prior to injection of glatiramer acetate']}], 'interventions': [{'name': 'glatiramer acetate', 'type': 'DRUG', 'otherNames': ['Copaxone'], 'armGroupLabels': ['1']}, {'name': 'Warm compress prior to injection of glatiramer acetate', 'type': 'PROCEDURE', 'otherNames': ['Copaxone'], 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Fullerton Neurology & Headache Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Center of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Springfield Neurology Associates', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Multiple Sclerosis Care Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Advanced Neurosciences Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Beach Neurology', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'overallOfficials': [{'name': 'MerriKay Oleen-Burkey, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Neuroscience, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Neuroscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Thomas Smith, M.D., Vice President, Medical Affairs', 'oldOrganization': 'Teva Neuroscience'}}}}