Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT00251758
Status:
COMPLETED
Last Update Posted:
2010-05-18
First Post:
2005-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064748', 'term': 'Dexlansoprazole'}, {'id': 'D064747', 'term': 'Lansoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Sr. VP Clinical Sciences', 'organization': 'Takeda Global Research & Development Center, Inc.'}, 'certainAgreement': {'otherDetails': 'No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 4 weeks.', 'otherNumAffected': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.', 'otherNumAffected': 55, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.', 'otherNumAffected': 54, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea (Excl Infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastrointestinal and Abdominal Pains (Excl Oral and Throat)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea and Vomiting Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headaches NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Cholecystitis and Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Non-site Specific Injuries Not Elsewhere Classified (NEC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Poisoning and Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 304, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '42.9'}, {'value': '45.7', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '75.0'}, {'value': '52.7', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '79.2'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.", 'groupDescription': 'The comparison between the two treatment groups was made using Wilcoxon rank-sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': "The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.", 'groupDescription': 'The comparison between the two treatment groups was made using Wilcoxon rank-sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.15505', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.', 'groupDescription': 'The comparison between the two treatment groups was made using Wilcoxon rank-sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes."}, {'type': 'PRIMARY', 'title': 'Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '44.8', 'spread': '33.8', 'groupId': 'OG001'}, {'value': '49.1', 'spread': '34.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes."}, {'type': 'SECONDARY', 'title': 'Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '81.3'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '92.9'}, {'value': '76.6', 'groupId': 'OG002', 'lowerLimit': '37.0', 'upperLimit': '92.6'}]}]}], 'analyses': [{'pValue': '0.00001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.", 'groupDescription': 'The comparison between the two treatment groups was made using Wilcoxon rank-sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': "The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.", 'groupDescription': 'The comparison between the two treatment groups was made using Wilcoxon rank-sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.38740', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.', 'groupDescription': 'The comparison between the two treatment groups was made using Wilcoxon rank-sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '34.1', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '34.5', 'groupId': 'OG001'}, {'value': '64.4', 'spread': '34.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 4 weeks.'}, {'id': 'FG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.'}, {'id': 'FG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '304'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '285'}, {'groupId': 'FG002', 'numSubjects': '277'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Unmet Inclusion/Exclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Noncompliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Per Subject Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Per Investigator Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects enrolled at 157 sites in the United States (75 in Study T-GD04-082 \\[NCT00251745\\] and 82 in Study T-GD04-083 \\[this posting, NCT00251758\\]; date of first dose: 07 December 2005; date of last procedure: 23 May 2006).', 'preAssignmentDetails': 'Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of Gastroesophageal Reflux Disease (GERD) should not be altered throughout the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}, {'value': '908', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 4 weeks.'}, {'id': 'BG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.'}, {'id': 'BG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '13.60', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '13.55', 'groupId': 'BG001'}, {'value': '46.7', 'spread': '13.64', 'groupId': 'BG002'}, {'value': '47.9', 'spread': '13.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '367', 'groupId': 'BG003'}]}]}, {'title': '45 - <65 years', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '440', 'groupId': 'BG003'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}, {'value': '643', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}, {'value': '731', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '729', '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 908}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-12', 'studyFirstSubmitDate': '2005-11-08', 'resultsFirstSubmitDate': '2009-02-26', 'studyFirstSubmitQcDate': '2005-11-08', 'lastUpdatePostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-20', 'studyFirstPostDateStruct': {'date': '2005-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.'}, {'measure': 'Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.'}, {'measure': 'Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean', 'timeFrame': '4 weeks', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://general.takedapharm.com/content/file/pi.pdf?applicationcode=9efb34b3-fb69-4190-a2be-a90b8cb94e25&filetypecode=DEXILANTPI', 'label': 'For the Dexilant Package Insert refer to this link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \\[QD\\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).', 'detailedDescription': 'This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a Screening Period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.\n\nBecause the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (NCT00241745) and T-GD04-083 (this posting, NCT00251758), were combined and analyzed as a single larger study, referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.\n\n * History of episodes of heartburn for 6 months or longer prior to screening.\n * History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.\n\nExclusion Criteria:\n\n* Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study\n* Erosive Esophagitis seen on endoscopy during study screening.\n* Co-existing diseases affecting the esophagus.\n* Abnormal laboratory values that suggest significant clinical disease.\n* Known acquired immunodeficiency syndrome (AIDS)\n* Females pregnant or lactating.\n* History of Alcohol abuse.\n* History of Cancer within 3 years prior to screening.\n* Chronic (\\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors\n* Use of antacids (except for study supplied Gelusil® )\n* Use of drugs with significant anticholinergic effects\n* Need for continuous anticoagulant (blood thinner) therapy\n* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus\n* History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)\n* Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition\n* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer\n* Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.\n* Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy"}, 'identificationModule': {'nctId': 'NCT00251758', 'briefTitle': 'Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)', 'orgStudyIdInfo': {'id': 'T-GD04-083'}, 'secondaryIdInfos': [{'id': 'U1111-1114-1811', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexlansoprazole MR 60 mg QD', 'interventionNames': ['Drug: Dexlansoprazole MR']}, {'type': 'EXPERIMENTAL', 'label': 'Dexlansoprazole MR 90 mg QD', 'interventionNames': ['Drug: Dexlansoprazole MR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexlansoprazole MR', 'type': 'DRUG', 'otherNames': ['TAK-390MR', 'Kapidex', 'Dexilant'], 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.', 'armGroupLabels': ['Dexlansoprazole MR 60 mg QD']}, {'name': 'Dexlansoprazole MR', 'type': 'DRUG', 'otherNames': ['TAK-390MR', 'Kapidex', 'Dexilant'], 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.', 'armGroupLabels': ['Dexlansoprazole MR 90 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'city': 'Hueytown', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.45122, 'lon': -86.99666}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Tallassee', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.53597, 'lon': -85.89329}}, {'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'city': 'Azusa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Cypress', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Modesto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'city': 'Bristol', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.67176, 'lon': -72.94927}}, {'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'city': 'New Smyrna Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02582, 'lon': -80.927}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'city': 'North Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.32558, 'lon': -87.84118}}, {'city': 'Oak Forest', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.60281, 'lon': -87.74394}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'city': 'Prince Frederick', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.5404, 'lon': -76.5844}}, {'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Egg Harbor', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.38646, 'lon': -74.60361}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Mogadore', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.04645, 'lon': -81.39789}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'city': 'Conroe', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.31188, 'lon': -95.45605}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Odessa', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.84568, 'lon': -102.36764}}, {'city': 'Pharr', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 26.1948, 'lon': -98.18362}}, {'city': 'Seguin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.56884, 'lon': -97.96473}}, {'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'city': 'Lakewood', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.17176, 'lon': -122.51846}}, {'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sr. VP, Clinical Science', 'oldOrganization': 'Takeda Global Research & Development Center, Inc.'}}}}