Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-28 @ 12:18 PM
Study NCT ID:
NCT00633932
Status:
COMPLETED
Last Update Posted:
2010-12-20
First Post:
2008-03-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reflux Esophagitis Phase III Study (Initial Treatment)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004942', 'term': 'Esophagitis, Peptic'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D009853', 'term': 'Omeprazole'}], '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': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'All PIs were prohibited to disclose all information related to this study withiout AZ approval before this study was completed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'One patient for each treatment group did not take any investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: Esomeprazole 40mg', 'description': 'Esomeprazole 40mg once daily', 'otherNumAtRisk': 190, 'otherNumAffected': 12, 'seriousNumAtRisk': 190, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental: Esomeprazole 20mg', 'description': 'Esomeprazole 20mg once daily', 'otherNumAtRisk': 189, 'otherNumAffected': 9, 'seriousNumAtRisk': 189, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Comparator: Omeprazole 20mg', 'description': 'Omeprazole 20mg once daily', 'otherNumAtRisk': 190, 'otherNumAffected': 16, 'seriousNumAtRisk': 190, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 190, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 190, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Esomeprazole 40mg', 'description': 'Esomeprazole 40mg once daily'}, {'id': 'OG001', 'title': 'Experimental: Esomeprazole 20mg', 'description': 'Esomeprazole 20mg once daily'}, {'id': 'OG002', 'title': 'Comparator: Omeprazole 20mg', 'description': 'Omeprazole 20mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \\< 5 mm in length), Grade B (Mucosal break \\> 5mm), Grade C (Mucosal break continuous between \\> 2 mucosal folds) and Grade D (Mucosal break \\>75% of esophageal circumference).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Esomeprazole 40mg', 'description': 'Esomeprazole 40mg once daily'}, {'id': 'OG001', 'title': 'Experimental: Esomeprazole 20mg', 'description': 'Esomeprazole 20mg once daily'}, {'id': 'OG002', 'title': 'Comparator: Omeprazole 20mg', 'description': 'Omeprazole 20mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \\< 5 mm in length), Grade B (Mucosal break \\> 5mm), Grade C (Mucosal break continuous between \\> 2 mucosal folds) and Grade D (Mucosal break \\>75% of esophageal circumference).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Esomeprazole 40mg', 'description': 'Esomeprazole 40mg once daily'}, {'id': 'FG001', 'title': 'Experimental: Esomeprazole 20mg', 'description': 'Esomeprazole 20mg once daily'}, {'id': 'FG002', 'title': 'Comparator: Omeprazole 20mg', 'description': 'Omeprazole 20mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomised', 'groupId': 'FG000', 'numSubjects': '191'}, {'comment': 'Randomised', 'groupId': 'FG001', 'numSubjects': '190'}, {'comment': 'Randomised', 'groupId': 'FG002', 'numSubjects': '191'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': "Doctor's judgement", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Moved Away', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First subject enrolled on 11 December 2007. Last subject completed on 12 December 2008.', 'preAssignmentDetails': "Out of 602 enrolled subjects, 572 subjects were randomised and 30 subjects were not randomised. The reasons of no randomisation were 'Incorrect enrollment' (25 subjects) and 'Voluntary discontinuation by Subject' (5 subjects)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}, {'value': '572', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Esomeprazole 40mg', 'description': 'Esomeprazole 40mg once daily'}, {'id': 'BG001', 'title': 'Experimental: Esomeprazole 20mg', 'description': 'Esomeprazole 20mg once daily'}, {'id': 'BG002', 'title': 'Comparator: Omeprazole 20mg', 'description': 'Omeprazole 20mg once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '388', 'groupId': 'BG003'}]}]}, {'title': '65 - 74 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '410', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2008-03-04', 'resultsFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2008-03-05', 'lastUpdatePostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-26', 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".', 'timeFrame': '8 weeks', 'description': 'Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \\< 5 mm in length), Grade B (Mucosal break \\> 5mm), Grade C (Mucosal break continuous between \\> 2 mucosal folds) and Grade D (Mucosal break \\>75% of esophageal circumference).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification', 'timeFrame': '4 weeks', 'description': 'Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \\< 5 mm in length), Grade B (Mucosal break \\> 5mm), Grade C (Mucosal break continuous between \\> 2 mucosal folds) and Grade D (Mucosal break \\>75% of esophageal circumference).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reflux Esophagitis'], 'conditions': ['Reflux Esophagitis']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation\n\nExclusion Criteria:\n\n* Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.\n* Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.'}, 'identificationModule': {'nctId': 'NCT00633932', 'briefTitle': 'Reflux Esophagitis Phase III Study (Initial Treatment)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis', 'orgStudyIdInfo': {'id': 'D961HC00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Esomeprazole 20mg', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Esomeprazole 40mg', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Omeprazole 20mg', 'interventionNames': ['Drug: Omeprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': '20mg once daily', 'armGroupLabels': ['1']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': '40 mg once daily', 'armGroupLabels': ['2']}, {'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['Prilosec'], 'description': '20mg once daily', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Akita', 'state': 'Akita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'city': 'Kisarazu', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.38329, 'lon': 139.93254}}, {'city': 'Kōriyama', 'state': 'Fukishima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.4, 'lon': 140.38333}}, {'city': 'Nihonmatsu', 'state': 'Fukishima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.96201, 'lon': 139.26427}}, {'city': 'Nishishirakawa', 'state': 'Fukishima', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Nukaya', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Shirakawa', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.11954, 'lon': 140.26211}}, {'city': 'Sugawa', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Yasunaka', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Hitachi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 140.65}}, {'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'city': 'Sakaidechō', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.32278, 'lon': 133.8356}}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Shibata', 'state': 'Myagi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.95, 'lon': 139.33333}}, {'city': 'Kiso', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.84036, 'lon': 137.69028}}, {'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Ōita', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Fujiidera', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.5676, 'lon': 135.5974}}, {'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Ohtawara', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Toshima-ku', 'state': 'Tokayo', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Adachi City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.76318, 'lon': 139.80761}}, {'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'city': 'Kiyose', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.77952, 'lon': 139.53014}}, {'city': 'Setagaya City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.64188, 'lon': 139.64715}}, {'city': 'Shinagawa', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Tottori-shi', 'state': 'Tottori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.5, 'lon': 134.23333}}, {'city': 'Shimonoseki', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.95548, 'lon': 130.93713}}], 'overallOfficials': [{'name': 'Maotsugu Oyama, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tore Lind / Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}