Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 10:22 AM
Study NCT ID:
NCT01201057
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2010-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeremy.paull@starpharma.com', 'title': 'Dr Jeremy Paull', 'organization': 'Starpharma'}, 'certainAgreement': {'otherDetails': 'For a multicenter study, the PIs can only publish after the results of the trial have been published collectively.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel', 'otherNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel', 'otherNumAtRisk': 32, 'otherNumAffected': 4, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel', 'otherNumAtRisk': 29, 'otherNumAffected': 5, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel', 'otherNumAtRisk': 32, 'otherNumAffected': 4, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Vulvovaginal burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Women With Clinical Cure as a Measure of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel'}, {'id': 'OG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 21-30', 'description': "Number of women with clinical cure as determined by absence of BV by the Amsel's criteria", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Women With Clinical Cure as a Measure of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel'}, {'id': 'OG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 9-12', 'description': "Number of women with clinical cure as determined by absence of BV by the Amsel's criteria", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Women With Nugent Cure as a Measure of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel'}, {'id': 'OG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 9-30', 'description': 'Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel'}, {'id': 'OG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 9-30', 'description': 'Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the mITT.'}, {'type': 'SECONDARY', 'title': 'Incidence of Genital Adverse Events Potentially Related to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel'}, {'id': 'OG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel'}, {'id': 'OG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'For the duration of the study (up to Visit Day 21-30)', 'description': 'Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure is adverse events, which are required to be reported separately under Adverse Events section.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel'}, {'id': 'FG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel'}, {'id': 'FG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel'}, {'id': 'FG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'No relevant events.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '0.5% SPL7013 Gel', 'description': '0.5% SPL7013 Gel: Vaginal gel'}, {'id': 'BG001', 'title': '1.0% SPL7013 Gel', 'description': '1.0% SPL7013 Gel: Vaginal gel'}, {'id': 'BG002', 'title': '3.0% SPL7013 Gel', 'description': '3.0% SPL7013 Gel: Vaginal gel'}, {'id': 'BG003', 'title': 'Placebo Gel', 'description': 'Placebo Gel: Vaginal gel'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '7.68', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '6.66', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '7.24', 'groupId': 'BG002'}, {'value': '30.6', 'spread': '7.66', 'groupId': 'BG003'}, {'value': '29.8', 'spread': '7.26', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'modified intent-to-treat population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2012-04-18', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2010-08-30', 'dispFirstSubmitQcDate': '2012-04-18', 'resultsFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2010-09-12', 'dispFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-03', 'studyFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Women With Clinical Cure as a Measure of Efficacy', 'timeFrame': 'Day 21-30', 'description': "Number of women with clinical cure as determined by absence of BV by the Amsel's criteria"}], 'secondaryOutcomes': [{'measure': 'Number of Women With Clinical Cure as a Measure of Efficacy', 'timeFrame': 'Day 9-12', 'description': "Number of women with clinical cure as determined by absence of BV by the Amsel's criteria"}, {'measure': 'Number of Women With Nugent Cure as a Measure of Efficacy', 'timeFrame': 'Day 9-30', 'description': 'Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.'}, {'measure': 'Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)', 'timeFrame': 'Day 9-30', 'description': 'Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.'}, {'measure': 'Incidence of Genital Adverse Events Potentially Related to Treatment', 'timeFrame': 'For the duration of the study (up to Visit Day 21-30)', 'description': 'Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.'}]}, 'conditionsModule': {'keywords': ['SPL7013', 'VivaGel', 'bacterial vaginosis', 'BV'], 'conditions': ['Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4\n* Otherwise healthy\n\nExclusion Criteria:\n\n* No active STIs"}, 'identificationModule': {'nctId': 'NCT01201057', 'briefTitle': 'Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Starpharma Pty Ltd'}, 'officialTitle': 'A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis', 'orgStudyIdInfo': {'id': 'SPL7013-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.5% SPL7013 Gel', 'interventionNames': ['Drug: 0.5% SPL7013 Gel']}, {'type': 'EXPERIMENTAL', 'label': '1.0% SPL7013 Gel', 'interventionNames': ['Drug: 1.0% SPL7013 Gel']}, {'type': 'EXPERIMENTAL', 'label': '3.0% SPL7013 Gel', 'interventionNames': ['Drug: 3.0% SPL7013 Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Gel', 'interventionNames': ['Other: Placebo Gel']}], 'interventions': [{'name': '0.5% SPL7013 Gel', 'type': 'DRUG', 'description': 'Vaginal gel', 'armGroupLabels': ['0.5% SPL7013 Gel']}, {'name': '1.0% SPL7013 Gel', 'type': 'DRUG', 'description': 'Vaginal gel', 'armGroupLabels': ['1.0% SPL7013 Gel']}, {'name': '3.0% SPL7013 Gel', 'type': 'DRUG', 'description': 'Vaginal gel', 'armGroupLabels': ['3.0% SPL7013 Gel']}, {'name': 'Placebo Gel', 'type': 'OTHER', 'description': 'Vaginal gel', 'armGroupLabels': ['Placebo Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Precision Trials', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Downtown Women's Health Care", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Center of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '75061', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Bexar Clinical Trials, LLC', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Clinical Research Inc', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'overallOfficials': [{'name': 'Anne Macek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'contracted to Starpharma Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Starpharma Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}