Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-30 @ 8:23 PM
Study NCT ID:
NCT01390792
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2011-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 622}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of incidence of adverse events in subjects treated with zanamivir', 'timeFrame': '11 days'}, {'measure': 'Occurrence of influenza virus infection', 'timeFrame': '11 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza, Human']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Keizo Matsumoto, Hideyuki Okano, Naomi Hasegawa, Ichiro Ohwaki, Shogo Inoshiri. Study on Preventive Effects of Zanamivir (Relenza) for Influenza. Medicine and Drug Journal. 2010;46(11):121-132.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\<Zanamivir prophylactic administration group\\> Subjects meeting all of the following criteria and starting prophylactic administration of zanamivir\n\n* family or persons living with patients with influenza virus infection\n* subjects meeting any of the following criteria, elderly subjects ( 65 years old and over), subjects with chronic cardiac disease, with metabolic disease (diabetes, etc.) or with renal dysfunction\n* unvaccinated persons during the applicable seasons\n* subjects whose consent to write influenza diary was obtained\n\n\\<Non-zanamivir prophylactic administration group\\>\n\n\\- subjects meeting all of the above criteria and NOT starting prophylactic administration of zanamivir', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who meet the study population criteria\n\nExclusion Criteria:\n\n* Subjects with a history of hypersensitivity to the ingredients of zanamivir'}, 'identificationModule': {'nctId': 'NCT01390792', 'briefTitle': 'Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)', 'orgStudyIdInfo': {'id': '112316'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects prescribed zanamivir', 'description': 'Subjects prescribed zanamivir during study period', 'interventionNames': ['Drug: Zanamivir hydrate']}], 'interventions': [{'name': 'Zanamivir hydrate', 'type': 'DRUG', 'armGroupLabels': ['Subjects prescribed zanamivir']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}