Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT01376193
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2011-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106783', 'term': 'naratriptan'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of incidence of adverse events in subjects with migraine headache', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence of cardiovascular-related adverse events', 'timeFrame': '2 months', 'description': 'Occurrence of cardiovascular-related adverse events is investigated throughout study period'}, {'measure': 'Occurrence of cerebrovascular disorder', 'timeFrame': '2 months', 'description': 'Occurrence of cerebrovascular disorder is investigated throughout study period'}, {'measure': 'Occurrence of serotonin syndrome', 'timeFrame': '2 months', 'description': 'Occurrence of serotonin syndrome is investigated throughout study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese subjects with migraine headache', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with migraine headache\n* Must use naratriptan tablets for the first time\n\nExclusion Criteria:\n\n* Subjects with hypersensitivity to naratriptan\n* Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina\n* Subjects with history of peripheral vascular disorder\n* Subjects with history of cerebrovascular disorder or transient ischemic attacks\n* Subjects with uncontrolled high-blood pressure\n* Subjects with severe hepatic function disorder or renal function disorder\n* Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist'}, 'identificationModule': {'nctId': 'NCT01376193', 'briefTitle': 'Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet', 'orgStudyIdInfo': {'id': '112924'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects prescribed naratriptan tablets', 'description': 'Subjects with migraine headache prescribed naratriptan tablets during study period', 'interventionNames': ['Drug: Naratriptan']}], 'interventions': [{'name': 'Naratriptan', 'type': 'DRUG', 'description': 'Collection of safety data', 'armGroupLabels': ['Subjects prescribed naratriptan tablets']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}