Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-02 @ 5:37 PM
Study NCT ID:
NCT02121002
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2014-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cedwards@amneal.com', 'phone': '631-974-7949', 'title': 'Candis Edwards', 'organization': 'Amneal Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.', 'eventGroups': [{'id': 'EG000', 'title': 'Diclofenac Sodium Topical Gel, 1%', 'description': 'Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nDiclofenac Sodium Topical Gel, 1%: Opaque, white gel', 'otherNumAtRisk': 391, 'deathsNumAtRisk': 391, 'otherNumAffected': 2, 'seriousNumAtRisk': 391, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Voltaren Topical Gel, 1%', 'description': 'Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nVoltaren Topical Gel, 1%: Opaque, white gel', 'otherNumAtRisk': 393, 'deathsNumAtRisk': 393, 'otherNumAffected': 2, 'seriousNumAtRisk': 393, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle Diclofenac Sodium Topical Gel', 'description': 'Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks\n\nVehicle Diclofenac Sodium Topical Gel: Opaque, white gel', 'otherNumAtRisk': 391, 'deathsNumAtRisk': 391, 'otherNumAffected': 3, 'seriousNumAtRisk': 391, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 393, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oedema,', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 393, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 393, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 393, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus and Rash Pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 393, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 393, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 4 Weeks in WOMAC Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Sodium Topical Gel, 1%', 'description': 'Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nDiclofenac Sodium Topical Gel, 1%: Opaque, white gel'}, {'id': 'OG001', 'title': 'Voltaren Topical Gel, 1%', 'description': 'Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nVoltaren Topical Gel, 1%: Opaque, white gel'}, {'id': 'OG002', 'title': 'Vehicle Diclofenac Sodium Topical Gel', 'description': 'Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks\n\nVehicle Diclofenac Sodium Topical Gel: Opaque, white gel'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2332', 'spread': '0.1160', 'groupId': 'OG000'}, {'value': '2.0287', 'spread': '0.1157', 'groupId': 'OG001'}, {'value': '-0.6387', 'spread': '0.1172', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Mean change from baseline to week 4 in the Western Ontario McMaster\n\nOsteoarthritis (WOMAC) pain score:\n\n5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Across study groups, the per protocol (PP) population included 1147 subjects (97.53%) and the modified intention-to-treat (mITT) population included 1166 subjects (99.15%).\n\nFor various reasons, 10 subjects were excluded from mITT population while 29 subjects were excluded from PP population out of 1176 subjects randomized in the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diclofenac Sodium Topical Gel, 1%', 'description': 'Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nDiclofenac Sodium Topical Gel, 1%: Opaque, white gel'}, {'id': 'FG001', 'title': 'Voltaren Topical Gel, 1%', 'description': 'Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nVoltaren Topical Gel, 1%: Opaque, white gel'}, {'id': 'FG002', 'title': 'Vehicle Diclofenac Sodium Topical Gel', 'description': 'Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks\n\nVehicle Diclofenac Sodium Topical Gel: Opaque, white gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '393'}, {'groupId': 'FG002', 'numSubjects': '391'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}, {'groupId': 'FG001', 'numSubjects': '389'}, {'groupId': 'FG002', 'numSubjects': '381'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Concomitant therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}, {'value': '1175', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Diclofenac Sodium Topical Gel, 1%', 'description': 'Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nDiclofenac Sodium Topical Gel, 1%: Opaque, white gel'}, {'id': 'BG001', 'title': 'Voltaren Topical Gel, 1%', 'description': 'Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks\n\nVoltaren Topical Gel, 1%: Opaque, white gel'}, {'id': 'BG002', 'title': 'Vehicle Diclofenac Sodium Topical Gel', 'description': 'Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks\n\nVehicle Diclofenac Sodium Topical Gel: Opaque, white gel'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<= 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'between 18 and 65 years', 'categories': [{'measurements': [{'value': '357', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}, {'value': '1062', 'groupId': 'BG003'}]}]}, {'title': '>=65year', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}, {'value': '753', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline participants in the Safety population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2015-06-23', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2014-04-21', 'dispFirstSubmitQcDate': '2015-06-23', 'resultsFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2014-04-21', 'dispFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-21', 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 4 Weeks in WOMAC Pain Score', 'timeFrame': 'Baseline and Week 4', 'description': 'Mean change from baseline to week 4 in the Western Ontario McMaster\n\nOsteoarthritis (WOMAC) pain score:\n\n5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.\n* Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.\n* After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee\n* If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study\n* Able to tolerate rescue medication with paracetamol/acetaminophen.\n\nExclusion Criteria:\n\n* Pregnant or lactating or planning to become pregnant during the study period.\n* X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.\n* History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.\n* After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.\n* History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.\n* History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.\n* History of gastrointestinal bleeding or peptic ulcer disease.\n* Use of warfarin or other anticoagulant therapy within 30 days of study randomization.\n* Elevated transaminases at screening.\n* Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.\n* Concomitant use of corticosteroids or use within 30 days of study randomization.\n* Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.\n* Known allergy to aspirin or nonsteroidal anti-inflammatory drug\n* Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.\n* Receipt of any drug as part of a research study within 30 days prior to screening.\n* Previous participation in this study.\n* Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).\n* Recent history of major knee injury or surgery.\n* Known history of positive HIV'}, 'identificationModule': {'nctId': 'NCT02121002', 'briefTitle': 'Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amneal Pharmaceuticals, LLC'}, 'officialTitle': 'A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'AM-DCG-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Sodium Topical Gel, 1%', 'description': 'Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks', 'interventionNames': ['Drug: Diclofenac Sodium Topical Gel, 1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voltaren Topical Gel, 1%', 'description': 'Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks', 'interventionNames': ['Drug: Voltaren Topical Gel, 1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Diclofenac Sodium Topical Gel', 'description': 'Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks', 'interventionNames': ['Drug: Vehicle Diclofenac Sodium Topical Gel']}], 'interventions': [{'name': 'Diclofenac Sodium Topical Gel, 1%', 'type': 'DRUG', 'description': 'Opaque, white gel', 'armGroupLabels': ['Diclofenac Sodium Topical Gel, 1%']}, {'name': 'Voltaren Topical Gel, 1%', 'type': 'DRUG', 'description': 'Opaque, white gel', 'armGroupLabels': ['Voltaren Topical Gel, 1%']}, {'name': 'Vehicle Diclofenac Sodium Topical Gel', 'type': 'DRUG', 'description': 'Opaque, white gel', 'armGroupLabels': ['Vehicle Diclofenac Sodium Topical Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500003', 'city': 'Secunderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Sunshine Hospitals'}, {'zip': '530002', 'city': 'Visakhapatnam', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'King George Hospital', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '380 015', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Rathi Orthopedic and Research Centre', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380016', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'B. J. Medical College & Hospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380061', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'GMERS Medical College and Hospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '362 001', 'city': 'Jūnāgadh', 'state': 'Gujarat', 'country': 'India', 'facility': 'Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra', 'geoPoint': {'lat': 21.51966, 'lon': 70.45981}}, {'zip': '390007', 'city': 'Vadodara', 'state': 'Gujarat', 'country': 'India', 'facility': 'Centre For Knee Surgery', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}, {'zip': '360007', 'city': 'Rajkot', 'state': 'Gujurat', 'country': 'India', 'facility': 'Shree Giriraj Multispeciality Hospital', 'geoPoint': {'lat': 22.29161, 'lon': 70.79322}}, {'zip': '560034', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'St Johns Medical College', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '590010', 'city': 'Belagavi', 'state': 'Karnataka', 'country': 'India', 'facility': 'K L E Societys Jawaharlal Nehry Medical College', 'geoPoint': {'lat': 15.85212, 'lon': 74.50447}}, {'zip': '570001', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Mysore Medical College', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '673008', 'city': 'Calicut', 'state': 'Kerala', 'country': 'India', 'facility': 'Government Medical College, Calicut', 'geoPoint': {'lat': 11.24802, 'lon': 75.7804}}, {'zip': '400022', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Psm Dept Ltmmc & Ltmg Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '440009', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Government Medical College', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '440010', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Jasleen Hospital', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '440019', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Lata Mangeshkar Hospital', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Bj Medical College', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '302023', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Malpani Multispeciality Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '625020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Apollo Speciality Hospitals', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'zip': '226 003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'M V Hospital and Research Centre', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'King Georges Medical University', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '403716', 'city': 'Goa', 'country': 'India', 'facility': 'Goa Medical College', 'geoPoint': {'lat': 24.60243, 'lon': 72.72583}}], 'overallOfficials': [{'name': 'Prayag Shah, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amneal Pharmaceuticals, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amneal Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sristek Clinical Research Solutions Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}