Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-28 @ 6:08 AM
Study NCT ID:
NCT01970995
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2013-10-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christelle.Haziza@pmi.com', 'phone': '+41 (58) 242 2625', 'title': 'Christelle HAZIZA, PhD', 'organization': 'Philip Morris Products S.A.'}, 'certainAgreement': {'otherDetails': "We confirm we have the contractual provisions in place which specifies that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.\n\nThe Intellectual Property rights and research results from the present study belongs to the Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the informed consent form signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, a 9-day confinement period followed by a 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).', 'description': 'The safety was assessed in the safety population, consisting of 160 subjects: 160 randomized subjects (78 in mTHS 2.2, 42 in mCC and 40 in SA) and no subject exposed to mTHS 2.2 from the product trial on Day -2 but not randomized.', 'eventGroups': [{'id': 'EG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting', 'otherNumAtRisk': 78, 'otherNumAffected': 16, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting", 'otherNumAtRisk': 42, 'otherNumAffected': 4, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting', 'otherNumAtRisk': 40, 'otherNumAffected': 4, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'OG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting"}, {'id': 'OG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting'}], 'classes': [{'categories': [{'measurements': [{'value': '83.21', 'groupId': 'OG000', 'lowerLimit': '73.51', 'upperLimit': '94.19'}, {'value': '617.04', 'groupId': 'OG001', 'lowerLimit': '521.87', 'upperLimit': '729.55'}, {'value': '83.57', 'groupId': 'OG002', 'lowerLimit': '70.32', 'upperLimit': '99.32'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.49', 'ciLowerLimit': '10.96', 'ciUpperLimit': '16.60', 'pValueComment': 'The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.', 'estimateComment': 'Geometric LS mean ratio mTHS 2.2:mCC', 'groupDescription': 'The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.\n\nAnalysis of the biomarker of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):\n\n* Null hypothesis (H0): m1≥m2\n* Alternative hypothesis (H1): m1\\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 days', 'description': 'Concentrations measured at Day 5 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.', 'unitOfMeasure': 'pg/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.'}, {'type': 'PRIMARY', 'title': 'Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'OG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting"}, {'id': 'OG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting'}], 'classes': [{'categories': [{'measurements': [{'value': '304.56', 'groupId': 'OG000', 'lowerLimit': '283.22', 'upperLimit': '327.50'}, {'value': '601.11', 'groupId': 'OG001', 'lowerLimit': '545.07', 'upperLimit': '662.91'}, {'value': '183.61', 'groupId': 'OG002', 'lowerLimit': '165.93', 'upperLimit': '203.18'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.67', 'ciLowerLimit': '44.88', 'ciUpperLimit': '57.20', 'pValueComment': 'The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.', 'estimateComment': 'Geometric LS mean ratio mTHS 2.2:mCC', 'groupDescription': 'The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.\n\nAnalysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):\n\n* Null hypothesis (H0): m1≥m2\n* Alternative hypothesis (H1): m1\\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 days', 'description': 'Concentrations measured at Day 5 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.', 'unitOfMeasure': 'ng/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.'}, {'type': 'PRIMARY', 'title': 'Concentration of S-phenylmercapturic Acid (S-PMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'OG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting"}, {'id': 'OG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting'}], 'classes': [{'categories': [{'measurements': [{'value': '119.18', 'groupId': 'OG000', 'lowerLimit': '107.73', 'upperLimit': '131.85'}, {'value': '1086.89', 'groupId': 'OG001', 'lowerLimit': '948.47', 'upperLimit': '1245.51'}, {'value': '104.83', 'groupId': 'OG002', 'lowerLimit': '91.07', 'upperLimit': '120.66'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.97', 'ciLowerLimit': '9.26', 'ciUpperLimit': '12.99', 'pValueComment': 'The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.', 'estimateComment': 'Geometric LS mean ratio mTHS 2.2:mCC', 'groupDescription': 'The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.\n\nAnalysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):\n\n* Null hypothesis (H0): m1≥m2\n* Alternative hypothesis (H1): m1\\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 days', 'description': 'Concentrations measured at Day 5 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.', 'unitOfMeasure': 'pg/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.'}, {'type': 'PRIMARY', 'title': 'Levels of Carboxyhemoglobin (COHb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'OG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting"}, {'id': 'OG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting'}], 'classes': [{'categories': [{'measurements': [{'value': '2.47', 'groupId': 'OG000', 'lowerLimit': '2.37', 'upperLimit': '2.57'}, {'value': '5.49', 'groupId': 'OG001', 'lowerLimit': '5.21', 'upperLimit': '5.79'}, {'value': '2.49', 'groupId': 'OG002', 'lowerLimit': '2.35', 'upperLimit': '2.63'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.94', 'ciLowerLimit': '42.11', 'ciUpperLimit': '47.97', 'pValueComment': 'The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.', 'estimateComment': 'Geometric LS mean ratio mTHS 2.2:mCC', 'groupDescription': 'The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.\n\nAnalysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):\n\n* Null hypothesis (H0): m1≥m2\n* Alternative hypothesis (H1): m1\\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '5 days', 'description': '% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.\n\nGeometric Least Squares means are provided as descriptive statistics.', 'unitOfMeasure': '% of saturation of hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.'}, {'type': 'PRIMARY', 'title': 'Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'OG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting"}, {'id': 'OG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting'}], 'classes': [{'categories': [{'measurements': [{'value': '22.48', 'groupId': 'OG000', 'lowerLimit': '18.82', 'upperLimit': '26.84'}, {'value': '96.65', 'groupId': 'OG001', 'lowerLimit': '76.63', 'upperLimit': '121.90'}, {'value': '14.90', 'groupId': 'OG002', 'lowerLimit': '11.67', 'upperLimit': '19.02'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.25', 'ciLowerLimit': '17.38', 'ciUpperLimit': '31.11', 'pValueComment': 'The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.', 'estimateComment': 'Geometric LS mean ratio mTHS 2.2:mCC', 'groupDescription': 'The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.\n\nAnalysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):\n\n* Null hypothesis (H0): m1≥m2\n* Alternative hypothesis (H1): m1\\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '90 days', 'description': 'Concentrations measured at Day 90 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.', 'unitOfMeasure': 'pg/mg creat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the period Day 60 to Day 90.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'FG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting"}, {'id': 'FG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting'}], 'periods': [{'title': 'Confinement Period (Population at Day 5)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'End of Study (Population at Day 90)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study initiated (first subject screened): 01 August 2013\n\nAt admission (Day -2), all the subjects performed a product trial of the THS 2.2 Menthol. During the baseline period, they continued smoking their single preferred brand of mCC. Then, on Day 0, they were randomized to one of the 3 study arms (mTHS 2.2, mCC or SA) in a 2:1:1 ratio.', 'preAssignmentDetails': 'Enrolled and randomized population = 160 subjects\n\n* 78 subjects in mTHS 2.2\n* 42 subjects in mCC\n* 40 subjects in SA\n\nNumber of subjects enrolled but NOT randomized (who tried the mTHS 2.2 at Day -2) = 0'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'BG001', 'title': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting"}, {'id': 'BG002', 'title': 'Smoking Abstinence (SA)', 'description': 'Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '10.58', 'groupId': 'BG000'}, {'value': '37.4', 'spread': '11.23', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '9.96', 'groupId': 'BG002'}, {'value': '37.2', 'spread': '10.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Daily mCC consumption at Screening', 'classes': [{'title': '10 to 19 cig/day', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': '> 19 cig/day', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Study population = all randomized subjects who had at least one post randomization product use experience and at least one valid biomarker of exposure measurement.\n\n160 randomized subjects: 78 in mTHS 2.2, 42 in mCC and 40 in SA arms\n\n155 completed, subjects who withdrew: 2 in mTHS 2.2, 1 in mCC and 2 in SA arms'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-04-07', 'size': 9012465, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-09T05:41', 'hasProtocol': True}, {'date': '2014-11-07', 'size': 3051953, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-09T05:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2013-10-18', 'resultsFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-14', 'studyFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)', 'timeFrame': '5 days', 'description': 'Concentrations measured at Day 5 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.'}, {'measure': 'Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)', 'timeFrame': '5 days', 'description': 'Concentrations measured at Day 5 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.'}, {'measure': 'Concentration of S-phenylmercapturic Acid (S-PMA)', 'timeFrame': '5 days', 'description': 'Concentrations measured at Day 5 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.'}, {'measure': 'Levels of Carboxyhemoglobin (COHb)', 'timeFrame': '5 days', 'description': '% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.\n\nGeometric Least Squares means are provided as descriptive statistics.'}, {'measure': 'Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)', 'timeFrame': '90 days', 'description': 'Concentrations measured at Day 90 in urine, adjusted for creatinine.\n\nGeometric Least Squares (LS) means are provided as descriptive statistics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Candidate modified risk tobacco product', 'Conventional cigarettes', 'Reduced exposure', 'HPHCs', 'Ambulatory'], 'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is Japanese.\n* Smoking, healthy subject as judged by the Investigator.\n* Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting.\n* Subject has smoked for at least the last 3 consecutive years.\n* Subject does not plan to quit smoking in the next 3 months.\n\nExclusion Criteria:\n\n* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).\n* The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer) which has an impact on cytochrome P450 1 A2 (CYP1A2) or cytochrome P450 2 A6 (CYP2A6) activity.\n* For women: Subject is pregnant or is breast feeding.\n* For women: Subject does not agree to use an acceptable method of effective contraception.'}, 'identificationModule': {'nctId': 'NCT01970995', 'briefTitle': 'Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'A Randomized, Controlled, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smokers Switching to THS 2.2 Menthol or Smoking Abstinence Compared to Smoking Menthol Conventional Cigarettes, for 90 Days', 'orgStudyIdInfo': {'id': 'ZRHM-REXA-07-JP'}, 'secondaryIdInfos': [{'id': 'ZRHM-REXA-07-JP', 'type': 'OTHER', 'domain': 'Philip Morris Products S.A.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THS 2.2 Menthol (mTHS 2.2)', 'description': 'Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting', 'interventionNames': ['Other: THS 2.2 Menthol (mTHS 2.2)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Smoking abstinence (SA)', 'description': 'Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting', 'interventionNames': ['Other: Smoking Abstinence (SA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Menthol Conventional Cigarette (mCC)', 'description': "Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting", 'interventionNames': ['Other: Menthol Conventional Cigarette (mCC)']}], 'interventions': [{'name': 'THS 2.2 Menthol (mTHS 2.2)', 'type': 'OTHER', 'description': 'THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting', 'armGroupLabels': ['THS 2.2 Menthol (mTHS 2.2)']}, {'name': 'Smoking Abstinence (SA)', 'type': 'OTHER', 'description': 'SA for 5 days in confinement prolonged by 85 days in an ambulatory setting', 'armGroupLabels': ['Smoking abstinence (SA)']}, {'name': 'Menthol Conventional Cigarette (mCC)', 'type': 'OTHER', 'description': "Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting", 'armGroupLabels': ['Menthol Conventional Cigarette (mCC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Masahiro Endo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaki Hospital Tokyo Heart Center'}, {'name': 'Christelle Haziza, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}