Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 12:06 PM
Study NCT ID:
NCT00717860
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2008-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
Sponsor:
Organization:
Raw JSON
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Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Caspofungin', 'description': 'Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.', 'otherNumAtRisk': 60, 'otherNumAffected': 44, 'seriousNumAtRisk': 60, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Micafungin', 'description': 'Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.', 'otherNumAtRisk': 60, 'otherNumAffected': 40, 'seriousNumAtRisk': 60, 'seriousNumAffected': 14}], 'otherEvents': 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'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 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[{'title': 'Drug-related adverse experience', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Serious drug-related adverse experience', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued by drug-related adverse experience', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis', 'description': 'A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population.'}, {'type': 'SECONDARY', 'title': 'Number of 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loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.'}, {'id': 'FG001', 'title': 'Micafungin', 'description': 'Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Clinical adverse experience', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Laboratory adverse experience', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Discontinued for other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caspofungin', 'description': 'Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.'}, {'id': 'BG001', 'title': 'Micafungin', 'description': 'Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2008-07-16', 'resultsFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2008-07-16', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-28', 'studyFirstPostDateStruct': {'date': '2008-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Significant Drug-related Adverse Experience', 'timeFrame': '1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis', 'description': 'A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Specific Safety Finding', 'timeFrame': '1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis', 'description': 'A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.'}, {'measure': 'Number of Participants With Favorable Overall Response at the End of Study Therapy', 'timeFrame': '1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis', 'description': 'Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.'}]}, 'conditionsModule': {'conditions': ['Fungal Infection']}, 'referencesModule': {'references': [{'pmid': '23052987', 'type': 'RESULT', 'citation': 'Kohno S, Izumikawa K, Yoshida M, Takesue Y, Oka S, Kamei K, Miyazaki Y, Yoshinari T, Kartsonis NA, Niki Y. A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis. Eur J Clin Microbiol Infect Dis. 2013 Mar;32(3):387-97. doi: 10.1007/s10096-012-1754-z. Epub 2012 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp.\n\nExclusion Criteria:\n\n* Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp.\n* Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In Screening Period.'}, 'identificationModule': {'nctId': 'NCT00717860', 'briefTitle': 'A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Double-Blind, Comparative Study of MK0991 (Caspofungin) Versus Micafungin in Adult Japanese Patients With Deep-seated Candida or Aspergillus Infections', 'orgStudyIdInfo': {'id': '0991-062'}, 'secondaryIdInfos': [{'id': '2008_013'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caspofungin', 'description': 'caspofungin acetate (MK0991)', 'interventionNames': ['Drug: caspofungin acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Micafungin', 'description': 'Micafungin sodium', 'interventionNames': ['Drug: Comparator: Micafungin sodium']}], 'interventions': [{'name': 'caspofungin acetate', 'type': 'DRUG', 'description': 'Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.', 'armGroupLabels': ['Caspofungin']}, {'name': 'Comparator: Micafungin sodium', 'type': 'DRUG', 'description': 'Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.', 'armGroupLabels': ['Micafungin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}