Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-26 @ 12:06 PM
Study NCT ID:
NCT03614494
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2018-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010894', 'term': 'Piroxicam'}, {'id': 'D016912', 'term': 'Levonorgestrel'}], 'ancestors': [{'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'raymondli@hku.hk', 'phone': '+852 22554517', 'title': 'Dr Raymond Li', 'organization': 'The University of Hong Kong'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 days', 'eventGroups': [{'id': 'EG000', 'title': 'Piroxicam', 'description': 'Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.', 'otherNumAtRisk': 418, 'deathsNumAtRisk': 430, 'otherNumAffected': 117, 'seriousNumAtRisk': 430, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.', 'otherNumAtRisk': 418, 'deathsNumAtRisk': 430, 'otherNumAffected': 133, 'seriousNumAtRisk': 430, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue / weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 23}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomachache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Pregnancies Prevented', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Piroxicam', 'description': 'Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}, {'value': '63.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.4', 'ciLowerLimit': '26.2', 'ciUpperLimit': '36.4', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': '(number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265).', 'unitOfMeasure': 'percentage of pregnancies prevented', 'reportingStatus': 'POSTED', 'populationDescription': 'efficacy-evaluable participants'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Piroxicam', 'description': 'Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.197', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.906', 'statisticalMethod': "Logistic regression, Firth's bias reduct", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'number of participants who were pregnant / number of efficacy-evaluable participants', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Piroxicam', 'description': 'Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '430'}, {'groupId': 'FG001', 'numSubjects': '430'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '418'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'A total of 860 women were recruited, all following the recruitment criteria, at the Family Planning Association of Hong Kong, between 20 August 2018 and 30 August 2022.', 'preAssignmentDetails': 'No per-assignment drop-out.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '860', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Piroxicam', 'description': 'Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose\n\n430 women enrolled and received study drugs as per protocol. 12 lost to follow-up. 418 women who were efficacy-evaluable.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '860', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '31.9', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '32.2', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '860', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese', 'categories': [{'measurements': [{'value': '416', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '833', 'groupId': 'BG002'}]}]}, {'title': 'Other Asians', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '860', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '21.9', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '21.8', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Coitus-treatment interval', 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '24.4', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '24.0', 'spread': '15.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-20', 'size': 204067, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-07T10:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 860}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2018-07-29', 'resultsFirstSubmitDate': '2023-01-07', 'studyFirstSubmitQcDate': '2018-07-29', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-28', 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Pregnancies Prevented', 'timeFrame': '1 month', 'description': '(number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265).'}], 'secondaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': '1 month', 'description': 'number of participants who were pregnant / number of efficacy-evaluable participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Piroxicam', 'Levonorgestrel', 'Placebo', 'Randomised controlled control', 'Emergency contraception'], 'conditions': ['Emergency Contraception']}, 'referencesModule': {'references': [{'pmid': '37597523', 'type': 'DERIVED', 'citation': 'Li RHW, Lo SST, Gemzell-Danielsson K, Fong CHY, Ho PC, Ng EHY. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial. Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised controlled trial aimed at comparing the efficacy of levonorgestrel (LNG) co-administered with piroxicam or placebo for oral emergency contraception (EC). Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a pain-killer in inflammatory conditions. Efficacy will be measured as the percentage of pregnancies prevented.', 'detailedDescription': 'Objective: To compare the percentage of pregnancies prevented by LNG co-administered with piroxicam or placebo for oral emergency contraception (EC) by a randomised controlled trial.\n\nHypothesis to be tested: LNG plus piroxicam has higher percentage of pregnancies prevented compared with LNG plus placebo for oral emergency contraception.\n\nDesign and subjects: This will be a prospective, randomised placebo-controlled clinical trial. Women attending the Family Planning Association of Hong Kong for oral EC within 72 hours of unprotected sexual intercourse will be recruited.\n\nStudy instruments: Prospective follow-up of subjects in the clinic for the primary and secondary outcomes.\n\nInterventions: Eligible subjects will be randomised to receive one of the two treatment regimens, i.e. Group A: a single dose of LNG 1.5 mg and piroxicam 40 mg, or Group B: a single dose of LNG 1.5mg and placebo under direct supervision.\n\nMain outcome measures: Percentage of pregnancies prevented (PPP) is the primary outcome measure. Secondary outcome measures include failure rate, rate of occurrence of side effects and pattern of the menstruation following EC.\n\nData analysis:The percentage of pregnancies prevented, failure rate and rate of occurrence of side effects will be compared between groups using Fisher-Exact test. Continuous variables regarding menstrual pattern between the two groups will be compared by Mann-Whitney U test.\n\nExpected results: LNG plus piroxicam has a higher PPP compared to LNG plus placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only females are eligible', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy women aged 18 years or above;\n* requesting emergency contraception within 72 h of a single act of unprotected intercourse in the current menstrual cycle;\n* having menstrual cycles between 24 and 42 days\n* willing to abstain from further acts of unprotected intercourse and;\n* available for follow-up over the next 6 weeks.\n\nExclusion Criteria:\n\n* post-abortion or postpartum and period have not yet returned,\n* being on prescription drugs currently\n* having unprotected intercourse in this cycle more than 72 hours or more than once before attending the clinic,\n* being found pregnant at the time of presentation,\n* breastfeeding,\n* having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ,\n* uncertain about the date of the last menstrual period,\n* having used hormonal contraceptive (including EC pill) or NSAID in the current or past one cycle,\n* having history of asthma, urticarial or other allergic reactions to piroxicam, aspirin or other NSAIDs,\n* having history of ischaemic heart disease in the past one year\n* having history of pelvic ulcer disease and/or gastrointestinal bleeding'}, 'identificationModule': {'nctId': 'NCT03614494', 'briefTitle': 'Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'UW18-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Piroxicam', 'description': 'Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose', 'interventionNames': ['Drug: Piroxicam 40 mg', 'Drug: Levonorgestrel 1.5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose', 'interventionNames': ['Drug: Levonorgestrel 1.5mg']}], 'interventions': [{'name': 'Piroxicam 40 mg', 'type': 'DRUG', 'description': 'Additional co-treatment', 'armGroupLabels': ['Piroxicam']}, {'name': 'Levonorgestrel 1.5mg', 'type': 'DRUG', 'description': 'Standard treatment', 'armGroupLabels': ['Piroxicam', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Family Planning Association of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Hang Wun Raymond Li, MD, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'starting 6 months after publication of results', 'ipdSharing': 'YES', 'description': 'To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.', 'accessCriteria': 'To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Hang Wun Raymond Li', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Family Planning Association of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Dr. Hang Wun Raymond Li', 'investigatorAffiliation': 'The University of Hong Kong'}}}}