Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT03426267
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Safety of SDN-037
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@sparcmail.com', 'phone': '912266455645', 'title': 'Head-Clinical Development', 'organization': 'Sun Pharma Advanced Research Company Limited'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 visits over a period of 22 to 36 days', 'eventGroups': [{'id': 'EG000', 'title': 'SDN-037', 'description': 'SDN-037: twice daily', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 87, 'seriousNumAtRisk': 154, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Placebo: twice daily', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 96, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anterior chamber cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 35}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anterior chamber flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 31}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 30}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 20}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 87, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 96, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Rhegmatogenous Retinal Detachment In Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Foot Infection Secondary To Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid Macula Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjects With an Anterior Chamber Cell Grade of 0 at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDN-037', 'description': 'SDN-037: twice daily'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Placebo: twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15', 'description': 'Grade Cell Count 0 0\n\n1. 1-10\n2. 11-20\n3. 21-50\n4. \\> 50\n\nACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \\>0 at Day 15 visit was considered a failure (or non-responder)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Subjects Who Achieve a Pain Score of 0 at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDN-037', 'description': 'SDN-037: twice daily'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Placebo: twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15', 'description': 'Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent \\>100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SDN-037', 'description': 'dosage: SDN-037\n\ndosage form: solution\n\nfrequency of administration: twice daily'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'dosage: Placebo\n\ndosage form: solution\n\nfrequency of administration: twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'Modified Intent-to-Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Prohibited Treatment Intake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SDN-037', 'description': 'SDN-037: twice daily'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Placebo: twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'spread': '8.61', 'groupId': 'BG000'}, {'value': '68.3', 'spread': '8.94', 'groupId': 'BG001'}, {'value': '68.3', 'spread': '8.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', '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': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '224', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'modified intent-to-treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-02', 'size': 1549877, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-03T08:20', 'hasProtocol': True}, {'date': '2020-09-17', 'size': 1000824, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-03T08:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2018-02-02', 'resultsFirstSubmitDate': '2021-03-03', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-14', 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjects With an Anterior Chamber Cell Grade of 0 at Day 15', 'timeFrame': 'Day 15', 'description': 'Grade Cell Count 0 0\n\n1. 1-10\n2. 11-20\n3. 21-50\n4. \\> 50\n\nACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \\>0 at Day 15 visit was considered a failure (or non-responder)'}], 'secondaryOutcomes': [{'measure': 'Subjects Who Achieve a Pain Score of 0 at Day 15', 'timeFrame': 'Day 15', 'description': 'Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent \\>100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation and Pain Associated With Ocular Surgery']}, 'descriptionModule': {'briefSummary': 'The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be at least 2 years of age on the date of assent or 18 years of age at the date of consent\n2. Be able and willing to follow study instructions and complete all required visits\n3. Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test\n4. Able to self-instill the IP or have a caregiver available to instil all doses of the IP\n\nExclusion Criteria:\n\n1. Any known allergy or hypersensitivity to difluprednate therapy\n2. An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye\n3. Any active corneal pathology noted in the study eye\n4. Currently suffering from alcohol and/or drug abuse'}, 'identificationModule': {'nctId': 'NCT03426267', 'briefTitle': 'Evaluation of Efficacy and Safety of SDN-037', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharma Advanced Research Company Limited'}, 'officialTitle': 'A Randomized, Double-Masked, Parallel Group, Multicenter, Study To Evaluate Efficacy And Safety of SDN -037 Twice Daily Compared With Vehicle For The Treatment Of Inflammation And Pain Associated With Ocular Surgery.', 'orgStudyIdInfo': {'id': 'CLR_16_31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SDN-037', 'interventionNames': ['Drug: SDN-037']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'vehicle', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SDN-037', 'type': 'DRUG', 'description': 'twice daily', 'armGroupLabels': ['SDN-037']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'twice daily', 'armGroupLabels': ['vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'SPARC Site 13', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85208', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'SPARC Site 14', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '86301', 'city': 'Prescott', 'state': 'Arizona', 'country': 'United States', 'facility': 'SPARC Site 11', 'geoPoint': {'lat': 34.54002, 'lon': -112.4685}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'SPARC Site 12', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'SPARC site 01', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '93110', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'SPARC Site 10', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80919', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'SPARC Site 08', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33067', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'SPARC Site 06', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'SPARC Site 18', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'SPARC Site 16', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'SPARC Site 07', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '42001', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'SPARC Site 15', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'SPARC Site 05', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'SPARC Site 09', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '12603', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'SPARC Site 03', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'SPARC Site 04', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'SPARC Site 17', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'SPARC Site 19', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78572', 'city': 'Mission', 'state': 'Texas', 'country': 'United States', 'facility': 'SPARC Site 2', 'geoPoint': {'lat': 26.21591, 'lon': -98.32529}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharma Advanced Research Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}