Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT01536704
Status:
COMPLETED
Last Update Posted:
2013-04-26
First Post:
2011-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nicotine Lozenge Bioequivalence Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.', 'eventGroups': [{'id': 'EG000', 'title': '2mg Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.', 'otherNumAtRisk': 47, 'otherNumAffected': 6, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.', 'otherNumAtRisk': 46, 'otherNumAffected': 9, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge', 'otherNumAtRisk': 45, 'otherNumAffected': 13, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge', 'otherNumAtRisk': 47, 'otherNumAffected': 15, 'seriousNumAtRisk': 47, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2mg Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}], 'classes': [{'categories': [{'measurements': [{'value': '18.84', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '20.71', 'spread': '7.42', 'groupId': 'OG001'}, {'value': '34.71', 'spread': '14.48', 'groupId': 'OG002'}, {'value': '33.68', 'spread': '12.17', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.91', 'ciLowerLimit': '0.88', 'ciUpperLimit': '0.94', 'estimateComment': 'Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.', 'groupDescription': 'The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.02', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.05', 'estimateComment': 'Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.', 'groupDescription': 'The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'AUC(0-t) was evaluated using the trapezoid rule.', 'unitOfMeasure': 'nanogram (ng).hour (hr)/millilitre (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done per intention to treat (ITT) population.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration [Cmaximum (Max)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2mg Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}], 'classes': [{'categories': [{'measurements': [{'value': '5.67', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '9.37', 'spread': '2.63', 'groupId': 'OG002'}, {'value': '9.72', 'spread': '2.70', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.85', 'ciUpperLimit': '0.94', 'estimateComment': 'Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.', 'groupDescription': 'The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.97', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.02', 'estimateComment': 'Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.', 'groupDescription': 'The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'Cmax was depicted from plasma concentration of nicotine.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done per intention to treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'AUC [0-infinity (Inf)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2mg Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}], 'classes': [{'categories': [{'measurements': [{'value': '21.03', 'spread': '8.05', 'groupId': 'OG000'}, {'value': '22.66', 'spread': '8.48', 'groupId': 'OG001'}, {'value': '37.48', 'spread': '16.87', 'groupId': 'OG002'}, {'value': '36.08', 'spread': '13.96', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciPctValue': '90', 'paramValue': '0.92', 'ciLowerLimit': '0.88', 'ciUpperLimit': '0.95', 'estimateComment': 'Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.', 'groupDescription': 'The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.02', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.06', 'estimateComment': 'Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.', 'groupDescription': 'The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'AUC (0-inf) was evaluated using the trapezoid rule.', 'unitOfMeasure': 'ng.hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done per intention to treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Nicotine Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2mg Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}, {'id': 'OG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.0'}, {'value': '0.67', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '2.0'}, {'value': '0.83', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '2.0'}, {'value': '0.83', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '0.1491', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0006', 'estimateComment': 'The median difference was calculated as Cherry minus Peppermint.', 'groupDescription': 'The null hypothesis considered that there is no median within-subject difference between two treatment groups.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The value of Tmax was adjusted for this non-parametric analysis.', 'testedNonInferiority': False}, {'pValue': '0.6790', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0005', 'estimateComment': 'The median difference was calculated as Cherry minus Peppermint.', 'groupDescription': 'The null hypothesis considered that there is no median within-subject difference between two treatment groups.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The value of Tmax was adjusted for this non-parametric analysis.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'Tmax was time at which Cmax of nicotine was reached.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done per intention to treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Apparent Elimination Half-life of Nicotine T(1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2mg Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'OG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'OG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'OG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.39', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '5.0'}, {'value': '3.41', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '6.6'}, {'value': '3.19', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '5.3'}, {'value': '3.13', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '5.3'}]}]}], 'analyses': [{'pValue': '0.5619', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.0641', 'estimateComment': 'The median difference was calculated as Cherry minus Peppermint.', 'groupDescription': 'The null hypothesis considered that there is no median within-subject difference between two treatment groups.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The value of T (1/2) was adjusted for this non-parametric analysis.', 'testedNonInferiority': False}, {'pValue': '0.4523', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0538', 'estimateComment': 'The median difference was calculated as Cherry minus Peppermint.', 'groupDescription': 'The null hypothesis considered that there is no median within-subject difference between two treatment groups.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The value of T (1/2) was adjusted for this non-parametric analysis.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'T(1/2) was calculated using plasma time-concentration values.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done per intention to treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Elimination Rate Constant for Plasma Nicotine: K (el)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2mg Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'OG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'OG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'OG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.5'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.5'}, {'value': '0.22', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '0.5'}, {'value': '0.22', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '0.5113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0025', 'estimateComment': 'The median difference was calculated as Cherry minus Peppermint.', 'groupDescription': 'The null hypothesis considered that there is no median within-subject difference between two treatment groups.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'This non-parametric analysis was performed on the unadjusted values of parameters.', 'testedNonInferiority': False}, {'pValue': '0.5370', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.0042', 'estimateComment': 'The median difference was calculated as Cherry minus Peppermint.', 'groupDescription': 'The null hypothesis considered that there is no median within-subject difference between two treatment groups.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'This non-parametric analysis was performed on the unadjusted values of parameters.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'Kel was calculated with the help of plasma time concentration values.', 'unitOfMeasure': '1/hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done per intention to treat (ITT) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2 Milligram (mg) Cherry Lozenge', 'description': 'Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'FG001', 'title': '2mg Mint Lozenge', 'description': 'Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'FG002', 'title': '4mg Cherry Lozenge', 'description': 'Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}, {'id': 'FG003', 'title': '4mg Mint Lozenge', 'description': 'Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG000', 'numSubjects': '13'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG001', 'numSubjects': '11'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG002', 'numSubjects': '10'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 1', 'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG001', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG002', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 2', 'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Washout Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG001', 'numSubjects': '11'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG002', 'numSubjects': '10'}, {'comment': 'Due to crossover design, a different set of subjects received this treatment compared to Period 3', 'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': 'Out of 141 participants screened, only 50 were randomized since 91 were screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Participants', 'description': 'All randomized participants were evaluated for baseline measures'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '9.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2011-12-15', 'resultsFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-14', 'studyFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'AUC(0-t) was evaluated using the trapezoid rule.'}, {'measure': 'Maximum Observed Plasma Concentration [Cmaximum (Max)]', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'Cmax was depicted from plasma concentration of nicotine.'}], 'secondaryOutcomes': [{'measure': 'AUC [0-infinity (Inf)]', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'AUC (0-inf) was evaluated using the trapezoid rule.'}, {'measure': 'Time to Reach Maximum Plasma Nicotine Concentration (Tmax)', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'Tmax was time at which Cmax of nicotine was reached.'}, {'measure': 'Apparent Elimination Half-life of Nicotine T(1/2)', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'T(1/2) was calculated using plasma time-concentration values.'}, {'measure': 'Elimination Rate Constant for Plasma Nicotine: K (el)', 'timeFrame': 'Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours', 'description': 'Kel was calculated with the help of plasma time concentration values.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nicotine lozenge', 'nicotine', 'nicotine replacement therapy'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.\n* Body Mass Index within the range 19-27 kilograms/meters\\^2\n\nExclusion Criteria:\n\n* Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit'}, 'identificationModule': {'nctId': 'NCT01536704', 'briefTitle': 'Nicotine Lozenge Bioequivalence Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges', 'orgStudyIdInfo': {'id': 'S6491365'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test nicotine lozenge (2 mg)', 'description': '2 mg test nicotine lozenge to be chewed.', 'interventionNames': ['Drug: Nicotine (2 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Test nicotine lozenge (4 mg)', 'description': '4 mg test nicotine lozenge to be chewed.', 'interventionNames': ['Drug: Nicotine (4 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference nicotine lozenge (2 mg)', 'description': '2 mg reference nicotine lozenge to be chewed.', 'interventionNames': ['Drug: Nicotine (2 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference nicotine lozenge (4 mg)', 'description': '4 mg reference nicotine lozenge to be chewed.', 'interventionNames': ['Drug: Nicotine (4 mg)']}], 'interventions': [{'name': 'Nicotine (2 mg)', 'type': 'DRUG', 'description': '2 mg nicotine lozenge in two formulations', 'armGroupLabels': ['Reference nicotine lozenge (2 mg)', 'Test nicotine lozenge (2 mg)']}, {'name': 'Nicotine (4 mg)', 'type': 'DRUG', 'description': '4 mg nicotine lozenge in two formulations', 'armGroupLabels': ['Reference nicotine lozenge (4 mg)', 'Test nicotine lozenge (4 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion NEBRASKA', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}