Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00240032
Status:
COMPLETED
Last Update Posted:
2011-04-11
First Post:
2005-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}, {'id': 'D017332', 'term': 'Cetirizine'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006919', 'term': 'Hydroxyzine'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2005-10-13', 'studyFirstSubmitQcDate': '2005-10-13', 'lastUpdatePostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injection Site Reaction', 'timeFrame': '5 weeks', 'description': 'Injection site reaction after taking antihistamine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* 18 years of age or older\n* Diagnosis of RRMS\n* Beginning or recently (within \\< 3months) began self-injecting Copaxone®\n\nExclusion Criteria:\n\n* Taking any other immunomodulatory therapy in conjunction with Copaxone®\n* Unable to perform subcutaneous self-injection\n* Pregnant or trying to become pregnant, or breast feeding during the study\n* Previously participated in this study or in another clinical trial in the past 30 days'}, 'identificationModule': {'nctId': 'NCT00240032', 'briefTitle': 'A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.', 'orgStudyIdInfo': {'id': 'PM014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Copaxone® with Zyrtec', 'interventionNames': ['Drug: glatiramer acetate injection with oral cetirizine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Copaxone® with placebo', 'interventionNames': ['Drug: glatiramer acetate with placebo']}], 'interventions': [{'name': 'glatiramer acetate injection with oral cetirizine hydrochloride', 'type': 'DRUG', 'otherNames': ['Copaxone®, Zyrtec®'], 'description': 'Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet', 'armGroupLabels': ['Copaxone® with Zyrtec']}, {'name': 'glatiramer acetate with placebo', 'type': 'DRUG', 'otherNames': ['Copaxone®'], 'description': 'Copaxone® injection 20 mg, oral placebo', 'armGroupLabels': ['Copaxone® with placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MerriKay Oleen-Burkey, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Neuroscience, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Thomas Smith, MD, VP Medical Affairs', 'oldOrganization': 'Teva Neuroscience'}}}}