Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT02631551
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialsdisclosuredesk@glenmarkpharma.com', 'phone': '(201) 684-8000', 'title': 'Study Director', '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 CRO/Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'GSP 301 NS', 'description': '2 sprays in each nostril twice daily for 14 days', 'otherNumAtRisk': 302, 'deathsNumAtRisk': 302, 'otherNumAffected': 0, 'seriousNumAtRisk': 302, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Olopatadine HCl NS', 'description': '2 sprays in each nostril twice daily for 14 days', 'otherNumAtRisk': 297, 'deathsNumAtRisk': 297, 'otherNumAffected': 0, 'seriousNumAtRisk': 297, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mometasone Furoate NS', 'description': '2 sprays in each nostril twice daily for 14 days', 'otherNumAtRisk': 294, 'deathsNumAtRisk': 294, 'otherNumAffected': 0, 'seriousNumAtRisk': 294, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'GSP 301 Placebo NS', 'description': '2 sprays in each nostril twice daily for 14 days', 'otherNumAtRisk': 287, 'deathsNumAtRisk': 287, 'otherNumAffected': 0, 'seriousNumAtRisk': 287, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 287, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSP 301 NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'OG001', 'title': 'Olopatadine HCl NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'OG002', 'title': 'Mometasone Furoate NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'OG003', 'title': 'GSP 301 Placebo NS', 'description': '2 sprays in each nostril twice daily for 14 days'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '10.2', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to end of treatment', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '3.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0587', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0755', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0043', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSP 301 NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'FG001', 'title': 'Olopatadine HCl NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'FG002', 'title': 'Mometasone Furoate NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'FG003', 'title': 'GSP 301 Placebo NS', 'description': '2 sprays in each nostril twice daily for 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '297'}, {'groupId': 'FG002', 'numSubjects': '294'}, {'groupId': 'FG003', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '278'}, {'groupId': 'FG002', 'numSubjects': '283'}, {'groupId': 'FG003', 'numSubjects': '276'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other, specific reasons not collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}, {'value': '1180', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GSP 301 NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'BG001', 'title': 'Olopatadine HCl NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'BG002', 'title': 'Mometasone Furoate NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'BG003', 'title': 'GSP 301 Placebo NS', 'description': '2 sprays in each nostril twice daily for 14 days'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '39.6', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '16.3', 'groupId': 'BG002'}, {'value': '39.4', 'spread': '14.8', 'groupId': 'BG003'}, {'value': '39.3', 'spread': '15.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}, {'value': '762', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '418', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '230', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '915', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2017-05-17', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2015-12-10', 'dispFirstSubmitQcDate': '2017-05-17', 'resultsFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2015-12-13', 'dispFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-18', 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.', 'timeFrame': '14 days', 'description': 'Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).'}]}, 'conditionsModule': {'keywords': ['Seasonal Allergic Rhinitis'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '31053180', 'type': 'DERIVED', 'citation': 'Hampel FC, Pedinoff AJ, Jacobs RL, Caracta CF, Tantry SK. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019 Jul 3;40(4):261-272. doi: 10.2500/aap.2019.40.4223. Epub 2019 May 3.'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 12 years and older inclusive of either sex.\n2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \\[Visit 1\\]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)\n3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Plans to travel outside the known pollen area for the investigative site for \\> 24 hours during the last 7 days of run in period.\n3. History of anaphylaxis and/or other severe local reaction(s) to skin testing.\n4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.\n5. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.\n6. Subjects with an active pulmonary disorder or infection.\n7. Subjects with posterior subcapsular cataracts or glaucoma'}, 'identificationModule': {'nctId': 'NCT02631551', 'acronym': 'GSP 301-301', 'briefTitle': 'Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glenmark Specialty S.A.'}, 'officialTitle': 'A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)', 'orgStudyIdInfo': {'id': 'GPL/CT/2014/016/III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSP 301 NS', 'interventionNames': ['Drug: GSP 301 NS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olopatadine HCl NS', 'interventionNames': ['Drug: Olopatadine HCl NS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mometasone furoate NS', 'interventionNames': ['Drug: Mometasone furoate NS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GSP 301 Placebo NS', 'interventionNames': ['Drug: GSP 301 Placebo NS']}], 'interventions': [{'name': 'GSP 301 NS', 'type': 'DRUG', 'description': 'FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days', 'armGroupLabels': ['GSP 301 NS']}, {'name': 'Olopatadine HCl NS', 'type': 'DRUG', 'description': '2 sprays in each nostril twice daily for 14 days', 'armGroupLabels': ['Olopatadine HCl NS']}, {'name': 'Mometasone furoate NS', 'type': 'DRUG', 'description': '2 sprays in each nostril twice daily for 14 days', 'armGroupLabels': ['Mometasone furoate NS']}, {'name': 'GSP 301 Placebo NS', 'type': 'DRUG', 'description': '2 sprays in each nostril twice daily for 14 days', 'armGroupLabels': ['GSP 301 Placebo NS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site 20', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site 31', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site 29', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site 25', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site 22', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site 10', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site 30', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site 37', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site 15', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site 23', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site 11', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site 14', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site 33', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site 26', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site 19', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site 21', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site 16', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'city': 'Skillman', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site 12', 'geoPoint': {'lat': 40.42011, 'lon': -74.7146}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site 36', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site 18', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site 27', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site 34', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site 32', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site 35', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Orangeburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site 13', 'geoPoint': {'lat': 33.49182, 'lon': -80.85565}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site 17', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 3', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 5', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 8', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Kerrville', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 1', 'geoPoint': {'lat': 30.04743, 'lon': -99.14032}}, {'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 7', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 2', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 4', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 6', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 9', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 28', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site 24', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}], 'overallOfficials': [{'name': 'Sudeesh Tantry, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glenmark Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glenmark Specialty S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}