Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-28 @ 11:57 PM
Study NCT ID:
NCT00803595
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multinational Phase III Study of CS-8958 (MARVEL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546919', 'term': 'CS 8958'}, {'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hmkessler@dsi.com', 'phone': '732-590-5032', 'title': 'Howard Kessler', 'organization': 'Daiichi Sankyo Pharma Development'}, 'certainAgreement': {'otherDetails': 'Principle investigator shall not publish the results of the study at any time without the prior written approval of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 days', 'eventGroups': [{'id': 'EG000', 'title': 'CS-8958 High Dose 40 mg', 'description': 'CS-8958 powder to be inhaled - high-dose arm', 'otherNumAtRisk': 337, 'otherNumAffected': 63, 'seriousNumAtRisk': 337, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CS-8958 Low Dose 20 mg', 'description': 'CS-8958 powder to be inhaled - low-dose arm', 'otherNumAtRisk': 326, 'otherNumAffected': 54, 'seriousNumAtRisk': 326, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Oseltamivir 75 mg', 'description': 'oseltamivir phosphate oral capsules', 'otherNumAtRisk': 336, 'otherNumAffected': 63, 'seriousNumAtRisk': 336, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Alanine aminotransferase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 336, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}, {'term': 'Wallenberg syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Japan (12.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Alleviation of Influenza Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CS-8958 High Dose 40 mg', 'description': 'CS-8958 powder to be inhaled - high-dose arm'}, {'id': 'OG001', 'title': 'CS-8958 Low Dose 20 mg', 'description': 'CS-8958 powder to be inhaled - low-dose arm'}, {'id': 'OG002', 'title': 'Oseltamivir 75 mg', 'description': 'oseltamivir phosphate oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '68.4', 'upperLimit': '80.8'}, {'value': '85.8', 'groupId': 'OG001', 'lowerLimit': '76.5', 'upperLimit': '92.8'}, {'value': '73.6', 'groupId': 'OG002', 'lowerLimit': '68.5', 'upperLimit': '83.3'}]}]}], 'analyses': [{'pValue': '0.748', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '6.9', 'pValueComment': '2-sided p-value without adjustments for multiple testing', 'groupDescription': 'This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \\>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.', 'statisticalMethod': 'Generalized Wilcoxon Test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A noninferiority margin of 18 hours (h) was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.8', 'ciLowerLimit': '-18.2', 'ciUpperLimit': '-0.4', 'pValueComment': '2-sided p-value without adjustments for multiple testing', 'groupDescription': 'Null hypothesis was that there was no difference in the time to illness alleviation', 'statisticalMethod': 'Generalized Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.104', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '17.2', 'groupDescription': 'This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \\>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.', 'statisticalMethod': 'Generalized Wilcoxon test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A noninferiority margin of 18 hours was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.'}], 'paramType': 'MEDIAN', 'timeFrame': '15 days', 'description': 'The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were "absent" or "mild." Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data.'}, {'type': 'SECONDARY', 'title': 'Time for Body Temperature to Return to Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CS-8958 High Dose 40 mg', 'description': 'CS-8958 powder to be inhaled - high-dose arm'}, {'id': 'OG001', 'title': 'CS-8958 Low Dose 20 mg', 'description': 'CS-8958 powder to be inhaled - low-dose arm'}, {'id': 'OG002', 'title': 'Oseltamivir 75 mg', 'description': 'oseltamivir phosphate oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '64.0'}, {'value': '58.0', 'groupId': 'OG001', 'lowerLimit': '52.3', 'upperLimit': '66.9'}, {'value': '54.7', 'groupId': 'OG002', 'lowerLimit': '48.2', 'upperLimit': '62.2'}]}]}], 'analyses': [{'pValue': '0.318', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '9.1', 'pValueComment': '2-sided P value without adjustments for multiple testing.', 'groupDescription': 'Null hypothesis was that there was no difference in the time for return to normal axillary temperature.', 'statisticalMethod': 'Generalized Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.981', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '5.7', 'pValueComment': '2-sided P value without adjustments for multiple testing.', 'groupDescription': 'Null hypothesis was that there was no difference in the time for return to normal axillary temperature.', 'statisticalMethod': 'Generalized Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.344', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '3.1', 'pValueComment': '2-sided P value without adjustments for multiple testing.', 'groupDescription': 'Null hypothesis was that there was no difference in the time for return to normal axillary temperature.', 'statisticalMethod': 'Generalized Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '15 days', 'description': 'Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CS-8958 High Dose 40 mg', 'description': 'CS-8958 powder to be inhaled - high-dose arm'}, {'id': 'FG001', 'title': 'CS-8958 Low Dose 20 mg', 'description': 'CS-8958 powder to be inhaled - low-dose arm'}, {'id': 'FG002', 'title': 'Oseltamivir 75 mg', 'description': 'oseltamivir phosphate oral capsules'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '327'}, {'groupId': 'FG002', 'numSubjects': '338'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '322'}, {'groupId': 'FG001', 'numSubjects': '319'}, {'groupId': 'FG002', 'numSubjects': '322'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This multicenter, double-blind,randomized, active-controlled trial was conducted from November 2008 through March 2009 at 117 institutions in Japan, Taiwan, Korea, and China (Hong Kong).', 'preAssignmentDetails': 'Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data. The data for the baseline characteristics is provided for this analysis set, not for all participants who entered the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}, {'value': '996', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CS-8958 High Dose 40 mg', 'description': 'CS-8958 powder to be inhaled - high-dose arm'}, {'id': 'BG001', 'title': 'CS-8958 Low Dose 20 mg', 'description': 'CS-8958 powder to be inhaled - low-dose arm'}, {'id': 'BG002', 'title': 'Oseltamivir 75 mg', 'description': 'oseltamivir phosphate oral capsules'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '35.6', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '35.0', 'spread': '11.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '477', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '519', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}, {'value': '996', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}, {'value': '785', 'groupId': 'BG003'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Laboratory confirmed influenza', 'classes': [{'title': 'Virus A/H1N1', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}, {'value': '645', 'groupId': 'BG003'}]}]}, {'title': 'Virus A/H3N2', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '322', 'groupId': 'BG003'}]}]}, {'title': 'Virus B', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1002}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2008-12-04', 'resultsFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-10-12', 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Alleviation of Influenza Illness', 'timeFrame': '15 days', 'description': 'The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were "absent" or "mild." Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored.'}], 'secondaryOutcomes': [{'measure': 'Time for Body Temperature to Return to Normal', 'timeFrame': '15 days', 'description': 'Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Neuraminidase inhibitor'], 'conditions': ['Influenza, Human']}, 'referencesModule': {'references': [{'pmid': '20936975', 'type': 'DERIVED', 'citation': 'Watanabe A, Chang SC, Kim MJ, Chu DW, Ohashi Y; MARVEL Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. Clin Infect Dis. 2010 Nov 15;51(10):1167-75. doi: 10.1086/656802. Epub 2010 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.\n\nIn a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of influenza\n* Axillary temperature of \\> or = to 37.5 degrees C\n\nExclusion Criteria:\n\n* Infection by bacteria species and/or virus other than influenza virus\n* Chronic respiratory disease\n* Renal dysfunction'}, 'identificationModule': {'nctId': 'NCT00803595', 'acronym': 'MARVEL', 'briefTitle': 'A Multinational Phase III Study of CS-8958 (MARVEL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Randomized Double-blind Controlled Study of CS-8958 Versus Oseltamivir Phosphate in Patients With Influenza Virus Infection', 'orgStudyIdInfo': {'id': 'CS8958-A-J301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CS-8958 Low Dose', 'description': 'CS-8958 powder to be inhaled - low-dose arm', 'interventionNames': ['Drug: CS-8958']}, {'type': 'EXPERIMENTAL', 'label': 'CS-8958 High Dose', 'description': 'CS-8958 powder to be inhaled - high-dose arm', 'interventionNames': ['Drug: CS-8958']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oseltamivir phosphate', 'description': 'oseltamivir phosphate oral capsules', 'interventionNames': ['Drug: oseltamivir phosphate']}], 'interventions': [{'name': 'CS-8958', 'type': 'DRUG', 'description': 'CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days', 'armGroupLabels': ['CS-8958 Low Dose']}, {'name': 'CS-8958', 'type': 'DRUG', 'description': 'CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days', 'armGroupLabels': ['CS-8958 High Dose']}, {'name': 'oseltamivir phosphate', 'type': 'DRUG', 'description': 'CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.', 'armGroupLabels': ['Oseltamivir phosphate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}