Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT00911534
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2009-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
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': 'D064750', 'term': 'Rabeprazole'}], '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': {'phone': '888-422-4743', 'title': 'Eisai Inc.', 'organization': 'Eisai Call Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For each participant, from the time participant signed the study consent form until resolution or for up to 30 days after study drug discontinuation, whichever came first.', 'description': 'The analysis was performed using the Safety Analysis Set (SAS) defined as all subjects who received at least 1 dose of study drug and had a postbaseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule', 'otherNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'RAB ER 50mg', 'description': 'One RAB ER 50mg capsule, orally, each day for 4 weeks', 'otherNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Cholecystitis, acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule'}, {'id': 'OG001', 'title': 'RAB ER 50mg', 'description': 'One RAB ER 50mg capsule, orally, each day for 4 weeks'}], 'classes': [{'title': 'Heartburn (Daytime)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Heartburn (Nighttime)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Regurgitation', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule'}, {'id': 'OG001', 'title': 'RAB ER 50mg', 'description': 'One RAB ER 50mg capsule, orally, each day for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '21.23', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '41.14', 'spread': '34.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.", 'unitOfMeasure': 'Percentage of Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug (n=number of participants with evaluable data)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Complete Heartburn Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule'}, {'id': 'OG001', 'title': 'RAB ER 50mg', 'description': 'One RAB ER 50mg capsule, orally, each day for 4 weeks'}], 'classes': [{'title': 'Week 2 (n=147, 148)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=147, 148)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2 and Week 4', 'description': 'Participants completed a daily symptom diary.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (n=number of participants with evaluable data)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Achieve First 24-Hour Period Without Heartburn', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule'}, {'id': 'OG001', 'title': 'RAB ER 50mg', 'description': 'One RAB ER 50mg capsule, orally, each day for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'Participants completed a daily symptom diary.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule'}, {'id': 'FG001', 'title': 'RAB ER 50mg', 'description': 'One RAB ER 50mg capsule, orally, each day for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized (treated)', 'groupId': 'FG000', 'numSubjects': '147'}, {'comment': 'Randomized (treated)', 'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Out of the 305 participants who were enrolled into the study, 300 participants received the study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule'}, {'id': 'BG001', 'title': 'RAB ER 50mg', 'description': 'One RAB ER 50mg capsule, orally, each day for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '13.32', 'groupId': 'BG000'}, {'value': '43.8', 'spread': '12.35', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '12.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2009-05-29', 'resultsFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2009-05-29', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Complete Heartburn Relief', 'timeFrame': 'Week 2 and Week 4', 'description': 'Participants completed a daily symptom diary.'}, {'measure': 'Time to Achieve First 24-Hour Period Without Heartburn', 'timeFrame': 'Baseline to Week 4', 'description': 'Participants completed a daily symptom diary.'}], 'primaryOutcomes': [{'measure': 'Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4', 'timeFrame': 'Week 4', 'description': "Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.'}]}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux Disease', 'GERD'], 'conditions': ['Symptomatic Gastroesophageal Reflux Disease (sGERD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "KEY INCLUSION CRITERIA:\n\nMale or female, ages 18 through 75 years will be included in the study. Females should be either of nonchildbearing potential or of childbearing potential. Females of childbearing potential must have negative serum and urine pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Women using hormonal contraceptives must also be using an additional approved method of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Pregnant or lactating females are excluded. Subjects must have a history of heartburn, identified as their main complaint, for 6 months or longer.Subjects must have documentation of a minimum of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of which occurs during the nighttime, during the last 7 days before randomization. Subjects must be able to read, write, and understand the language of the symptom dairy.\n\nKEY EXCLUSION CRITERIA:\n\nSubjects will be excluded from the study if they are found to have erosive esophagitis during esophagogastroduodenoscopy (EGD) at Screening, current or a history of esophageal motility disorders, current or a history of Barrett's esophagus, current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications), current or a history of Zollinger-Ellison syndrome and acid hypersecretory conditions, or current gastric or duodenal ulcer. Subjects will be excluded if they are found to have current or a history of cancer, with the exception of fully excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal, gastric and duodenal surgery, except simple closure of a perforated ulcer. Subjects will be excluded who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\\>=20 mg/day prednisone or equivalent), or aspirin (\\>325 mg/day). Female subjects will be excluded who are pregnant, lactating, or have a positive B-human gonadotropin test at Screening/Baseline. Subjects will be excluded who are known to be human immunodeficiency virus (HIV) positive, have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial. Subjects who are unwilling to provide informed consent will be excluded."}, 'identificationModule': {'nctId': 'NCT00911534', 'briefTitle': 'Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Multicenter Randomized Double-Blind Study to Compare the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)', 'orgStudyIdInfo': {'id': 'E3810-A001-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: rabeprazole sodium']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'rabeprazole sodium', 'type': 'DRUG', 'otherNames': ['rabeprazole sodium extended release'], 'description': 'One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35611', 'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.80243, 'lon': -86.97219}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90301', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95340', 'city': 'Merced', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.30216, 'lon': -120.48297}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92869', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '6606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33904', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32168', 'city': 'New Smyrna Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02582, 'lon': -80.927}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '33542', 'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30263', 'city': 'Newnam', 'state': 'Georgia', 'country': 'United States'}, {'zip': '60622', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21742', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '20636', 'city': 'Hollywood', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.07511, 'lon': -76.5858}}, {'zip': '48047', 'city': 'Chesterfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.66281, 'lon': -82.84242}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55318', 'city': 'Chaska', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.78941, 'lon': -93.60218}}, {'zip': '65265', 'city': 'Mexico', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.16976, 'lon': -91.88295}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '8035', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '7712', 'city': 'Ocean City', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.27762, 'lon': -74.5746}}, {'zip': '8360', 'city': 'Vineland', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.48623, 'lon': -75.02573}}, {'zip': '8043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '14534', 'city': 'Pittsford', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.09062, 'lon': -77.515}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28607', 'city': 'Boone', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.21679, 'lon': -81.67455}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': "277'13", 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '27265', 'city': 'Greesnboro', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '28546', 'city': 'Jacksonville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.75405, 'lon': -77.43024}}, {'zip': '28501', 'city': 'Kinston', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.26266, 'lon': -77.58164}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28671', 'city': 'Rutherford College', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.74846, 'lon': -81.52259}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45631', 'city': 'Gallipolis', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 38.8098, 'lon': -82.20237}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '43551', 'city': 'Perrysburg', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.557, 'lon': -83.62716}}, {'zip': '73071', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '37601', 'city': 'Joshson City', 'state': 'Tennessee', 'country': 'United States'}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75110', 'city': 'Corsicana', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.09543, 'lon': -96.46887}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78041', 'city': 'Laredo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 27.50641, 'lon': -99.50754}}, {'zip': '79761', 'city': 'Odessa', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.84568, 'lon': -102.36764}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Texas', 'country': 'United States'}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84120', 'city': 'West Valley City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.69161, 'lon': -112.00105}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '24073', 'city': 'Christiansburg', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.12985, 'lon': -80.40894}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53209', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53566', 'city': 'Monroe', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 42.60112, 'lon': -89.63845}}], 'overallOfficials': [{'name': 'Guillermo Rossiter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}