Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-07 @ 3:46 PM
Study NCT ID:
NCT04446312
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studydirector@sebelapharma.com', 'phone': '781-843-2202', 'title': 'Head of R&D, GI', 'organization': 'Braintree Laboratories, Inc.'}, 'certainAgreement': {'otherDetails': 'The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.', 'eventGroups': [{'id': 'EG000', 'title': 'BLI4900', 'description': 'Experimental bowel preparation solution for oral ingestion\n\nBowel Prep: Orally ingested liquid bowel preparation', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 23, 'seriousNumAtRisk': 227, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FDA Approved Control', 'description': 'FDA approved bowel preparation solution for oral ingestion\n\nBowel Prep: Orally ingested liquid bowel preparation', 'otherNumAtRisk': 226, 'deathsNumAtRisk': 226, 'otherNumAffected': 26, 'seriousNumAtRisk': 226, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '1.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With Successful Bowel Preparation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLI4900', 'description': 'Experimental bowel preparation solution for oral ingestion\n\nBowel Prep: Orally ingested liquid bowel preparation'}, {'id': 'OG001', 'title': 'FDA Approved Control', 'description': 'FDA approved bowel preparation solution for oral ingestion\n\nBowel Prep: Orally ingested liquid bowel preparation'}], 'classes': [{'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-3.97', 'ciUpperLimit': '4.27', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The pre-defined non-inferiority margin was 10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 days', 'description': 'Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population - this population includes all subjects that took any portion of study preparation and who did not withdraw for a reason other than safety, efficacy or tolerance.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BLI4900', 'description': 'Experimental bowel preparation solution for oral ingestion\n\nBowel Prep (powder for oral solution): Orally ingested liquid bowel preparation (1 liter per dose)'}, {'id': 'FG001', 'title': 'FDA Approved Control', 'description': 'FDA approved bowel preparation solution for oral ingestion\n\nBowel Prep (liquid for reconstitution): Orally ingested liquid bowel preparation (16 oz per dose)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '44'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BLI4900', 'description': 'Experimental bowel preparation solution for oral ingestion\n\nBowel Prep: Orally ingested liquid bowel preparation'}, {'id': 'BG001', 'title': 'FDA Approved Control', 'description': 'FDA approved bowel preparation solution for oral ingestion\n\nBowel Prep: Orally ingested liquid bowel preparation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '56.2', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Baseline Analysis Population represents the Intent-to-Treat Population which includes all patients that were dispensed a study preparation kit.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-10', 'size': 1592413, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-29T17:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2020-06-22', 'resultsFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-25', 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With Successful Bowel Preparation', 'timeFrame': '2 days', 'description': 'Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '37490604', 'type': 'DERIVED', 'citation': 'Bhandari R, Goldstein M, Mishkin DS, McGowan J, Cleveland MV, Di Palma JA. Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy. J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 10.1097/MCG.0000000000001894.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.\n* 18 to 85 years of age (inclusive)\n* If female, and of child-bearing potential, is using an acceptable form of birth control.\n* Negative serum pregnancy test at screening, if applicable\n* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.\n* Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.\n* Subjects who had previous significant gastrointestinal surgeries.\n* Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation\n* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.\n* Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.\n* Subjects with uncontrolled hypertension.\n* Subjects taking antibiotics within 7 days of colonoscopy.\n* Subjects with severe renal, hepatic or cardiac insufficiency.\n* Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.\n* Subjects undergoing insulin therapy for any indication.\n* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.\n* Subjects undergoing colonoscopy for foreign body removal and/or decompression.\n* Subjects taking tricyclic antidepressants.\n* Subjects using drugs of abuse, including abused prescription medications.\n* Subjects who are withdrawing from alcohol or benzodiazepines."}, 'identificationModule': {'nctId': 'NCT04446312', 'briefTitle': 'Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braintree Laboratories'}, 'officialTitle': 'A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy', 'orgStudyIdInfo': {'id': 'BLI4900-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLI4900', 'description': 'Experimental bowel preparation solution for oral ingestion', 'interventionNames': ['Drug: Bowel Prep']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FDA Approved Control', 'description': 'FDA approved bowel preparation solution for oral ingestion', 'interventionNames': ['Drug: Bowel Prep']}], 'interventions': [{'name': 'Bowel Prep', 'type': 'DRUG', 'description': 'Orally ingested liquid bowel preparation', 'armGroupLabels': ['BLI4900', 'FDA Approved Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': '302 Research Site 2', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': '302 Research Site 10', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': '302 Research Site 11', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': '302 Research Site 9', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '302 Research Site 31', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06010', 'city': 'Bristol', 'state': 'Connecticut', 'country': 'United States', 'facility': '302 Research Site 22', 'geoPoint': {'lat': 41.67176, 'lon': -72.94927}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': '302 Research Site 17', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': '302 Research Site 3', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': '302 Research Site 14', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33134', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '302 Research Site 28', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '302 Research Site 29', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '302 Research Site 30', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': '302 Research Site 38', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': '302 Research Site 5', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': '302 Research Site 34', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70471', 'city': 'Mandeville', 'state': 'Louisiana', 'country': 'United States', 'facility': '302 Research Site 26', 'geoPoint': {'lat': 30.35825, 'lon': -90.06563}}, {'zip': '71201', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': '302 Research Site 36', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '21742', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': '302 Research Site 16', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': '302 Research Site 39', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': '302 Research Site 37', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': '302 Research Site 8', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': '302 Research Site 25', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': '302 Research Site 1', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28403', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': '302 Research Site 13', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': '302 Research Site 18', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': '302 Research Site 23', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': '302 Research Site 33', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '78613', 'city': 'Cedar Park', 'state': 'Texas', 'country': 'United States', 'facility': '302 Research Site 32', 'geoPoint': {'lat': 30.5052, 'lon': -97.82029}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '302 Research Site 21', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76092', 'city': 'Southlake', 'state': 'Texas', 'country': 'United States', 'facility': '302 Research Site 35', 'geoPoint': {'lat': 32.94124, 'lon': -97.13418}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': '302 Research Site 27', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': '302 Research Site 6', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': '302 Research Site 4', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': '302 Research Site 7', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'John McGowan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Braintree Laboratories / Sebela Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braintree Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}