Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-23 @ 11:16 PM
Study NCT ID:
NCT02596451
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).
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': 'clinicaltrialsdisclosuredesk@glenmarkpharma.com', 'phone': '91 2267720000', 'title': 'Cathy Tyrrell', 'organization': 'Glenmark Pharmaceuticals Ltd'}, 'certainAgreement': {'otherDetails': 'Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)', 'otherNumAtRisk': 383, 'otherNumAffected': 28, 'seriousNumAtRisk': 383, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference', 'description': 'Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)', 'otherNumAtRisk': 382, 'otherNumAffected': 26, 'seriousNumAtRisk': 382, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Vehicle gel (Glenmark Pharmaceuticals Ltd)', 'otherNumAtRisk': 378, 'otherNumAffected': 23, 'seriousNumAtRisk': 378, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 382, 'numEvents': 46, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 36, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 382, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 382, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 382, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'L Ankle Surgery Secondary To Trimalleolar Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 382, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Ankle Surgery Due To Stair Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'notes': 'This SAE was occured during the baseline lead-in period of the study and subject did not use the study product.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '3.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4', 'description': "The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test', 'description': 'Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)'}, {'id': 'FG001', 'title': 'Reference', 'description': 'Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Vehicle gel (Glenmark Pharmaceuticals Ltd)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}, {'groupId': 'FG001', 'numSubjects': '392'}, {'groupId': 'FG002', 'numSubjects': '387'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '381'}, {'groupId': 'FG001', 'numSubjects': '374'}, {'groupId': 'FG002', 'numSubjects': '373'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'BG000'}, {'value': '382', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}, {'value': '1143', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test', 'description': 'Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)'}, {'id': 'BG001', 'title': 'Reference', 'description': 'Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Vehicle gel (Glenmark Pharmaceuticals Ltd)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'spread': '10.36', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '10.68', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '10.52', 'groupId': 'BG002'}, {'value': '56.4', 'spread': '10.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '734', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '409', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 1164 subjects were randomized in the study; however there were 21 subjects excluded from the safety population randomized who did not received dose. (Test=2, Reference=10, Placebo=9). Therefore the subject numbers are not consistent with any of the rows in the Participant Flow module.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2015-11-03', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee', 'timeFrame': 'Baseline and week 4', 'description': "The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.\n2. OA Symptoms for at least 6 months prior to screening.\n3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of \\> 9 on a 20 point scale for the target knee immediately prior to randomization.\n\nExclusion Criteria:\n\n1. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.\n2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.\n3. History of gastrointestinal bleeding or peptic ulcer disease.\n4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).\n5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.\n6. Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.'}, 'identificationModule': {'nctId': 'NCT02596451', 'briefTitle': 'To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glenmark Pharmaceuticals Ltd. India'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee', 'orgStudyIdInfo': {'id': 'GLK-1402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Sodium gel, 1%', 'description': 'apply gel to the target knee', 'interventionNames': ['Drug: Diclofenac Sodium gel, 1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voltaren® Gel', 'description': 'apply gel to the target knee', 'interventionNames': ['Drug: Voltaren® Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'apply gel to the target knee', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diclofenac Sodium gel, 1%', 'type': 'DRUG', 'armGroupLabels': ['Diclofenac Sodium gel, 1%']}, {'name': 'Voltaren® Gel', 'type': 'DRUG', 'armGroupLabels': ['Voltaren® Gel']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Glenmark Investigational Site 5', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 1', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 21', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 31', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 26', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 42', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 30', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 33', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 25', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 24', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 2', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Rancho Cucamonga', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 13', 'geoPoint': {'lat': 34.1064, 'lon': -117.59311}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 27', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 10', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 41', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 15', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 19', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 28', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 32', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 40', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 3', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 37', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 11', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 18', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Glenmark Investigational Site 8', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Glenmark Investigational Site 43', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 38', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Glenmark Investigational Site 17', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Glenmark Investigational Site 22', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Glenmark Investigational Site 14', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Englewood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Glenmark Investigational Site 9', 'geoPoint': {'lat': 39.87756, 'lon': -84.30217}}, {'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Glenmark Investigational Site7', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Glenmark Investigational Site 36', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Glenmark Investigational Site 39', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 23', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 20', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 34', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 35', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 44', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Lampasas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 4', 'geoPoint': {'lat': 31.06378, 'lon': -98.1817}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 29', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 6', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Glenmark Investigational Site 16', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': 'Glenmark Investigational Site12', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}], 'overallOfficials': [{'name': 'Mahesh V Deshpande', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glenmark Pharmaceuticals Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glenmark Pharmaceuticals Ltd. India', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}