Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT02870205
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2016-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of GSP 301 Nasal Spray 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., 7-10 days of screening and placebo run-in and 14 days of treatment.', 'description': 'Mometasone furoate NS: 1 subject received wrong kit and was excluded', 'eventGroups': [{'id': 'EG000', 'title': 'GSP 301 Placebo NS', 'description': '2 sprays/nostril twice daily for 14 days', 'otherNumAtRisk': 294, 'otherNumAffected': 0, 'seriousNumAtRisk': 294, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GSP 301 NS', 'description': '2 sprays/nostril twice daily for 14 days', 'otherNumAtRisk': 294, 'otherNumAffected': 0, 'seriousNumAtRisk': 294, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Olopatadine HCl NS', 'description': '2 sprays/nostril twice daily for 14 days', 'otherNumAtRisk': 294, 'otherNumAffected': 0, 'seriousNumAtRisk': 294, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Mometasone Furoate NS', 'description': '2 sprays/nostril twice daily for 14 days', 'otherNumAtRisk': 293, 'otherNumAffected': 0, 'seriousNumAtRisk': 293, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '293', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSP 301 Placebo NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'OG001', 'title': 'GSP 301 NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'OG002', 'title': 'Olopatadine HCl NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'OG003', 'title': 'Mometasone Furoate NS', 'description': '2 sprays/nostril twice daily for 14 days'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '10.2', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to end of treatment', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '3.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.028', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 14', 'description': 'The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged 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 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 Placebo NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'FG001', 'title': 'GSP 301 NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'FG002', 'title': 'Olopatadine HCl NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'FG003', 'title': 'Mometasone Furoate NS', 'description': '2 sprays/nostril twice daily for 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '294'}, {'groupId': 'FG002', 'numSubjects': '294'}, {'groupId': 'FG003', 'numSubjects': '294'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '289'}, {'groupId': 'FG002', 'numSubjects': '287'}, {'groupId': 'FG003', 'numSubjects': '287'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}, {'value': '293', 'groupId': 'BG003'}, {'value': '1172', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GSP 301 Placebo NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'BG001', 'title': 'GSP 301 NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'BG002', 'title': 'Olopatadine HCl NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'BG003', 'title': 'Mometasone Furoate NS', 'description': '2 sprays/nostril twice daily for 14 days'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '14.93', 'groupId': 'BG000'}, {'value': '39.9', 'spread': '14.91', 'groupId': 'BG001'}, {'value': '39.9', 'spread': '14.62', 'groupId': 'BG002'}, {'value': '39.2', 'spread': '14.86', 'groupId': 'BG003'}, {'value': '39.6', 'spread': '14.81', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}, {'value': '737', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}, {'value': '435', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': "GSP 301 placebo NS: Due to repeated participation of same subject in 2 seasons, only 1 participation (fall period) was included; Mometasone furoate NS: 1 subject received wrong kit and was excluded; GSP 301 NS and olopatadine HCl NS: Due to coinciding participation of same subject at 2 different sites, both participation's were excluded."}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2016-08-12', 'resultsFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-05', 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)', 'timeFrame': 'Baseline and day 14', 'description': 'The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged 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': {'conditions': ['Seasonal Allergic Rhinitis (SAR)']}, 'referencesModule': {'references': [{'pmid': '30910440', 'type': 'DERIVED', 'citation': 'Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.'}], 'seeAlsoLinks': [{'url': 'http://epostersonline.com/acaai2017/node/1113', 'label': 'Poster presentation at the "2017 Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology"'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and non-pregnant females who are 12 years of age and older.\n* Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \\[Visit 1\\]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)\n* A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* History of anaphylaxis and/or other severe local reaction(s) to skin testing.\n* History of positive test for HIV, Hepatitis B or Hepatitis C infection.\n* Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.\n* Subjects with an active pulmonary disorder or infection.\n* Subjects with posterior subcapsular cataracts or glaucoma\n* Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.'}, 'identificationModule': {'nctId': 'NCT02870205', 'acronym': 'GSP 301-304', 'briefTitle': 'Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glenmark Specialty S.A.'}, 'officialTitle': 'A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)', 'orgStudyIdInfo': {'id': 'GPL/CT/2015/004/III'}, 'secondaryIdInfos': [{'id': 'Study Number: GSP 301-304', 'type': 'OTHER', 'domain': 'Glenmark Specialty S.A.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSP 301 NS', 'interventionNames': ['Drug: GSP 301 NS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GOM-NS', 'interventionNames': ['Drug: GOM-NS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GMM-2 NS', 'interventionNames': ['Drug: GMM-2 NS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GSP 301 placebo NS', 'interventionNames': ['Drug: GSP 301 placebo NS']}], 'interventions': [{'name': 'GSP 301 NS', 'type': 'DRUG', 'description': '2 spray in each nostril twice daily for 14 days', 'armGroupLabels': ['GSP 301 NS']}, {'name': 'GOM-NS', 'type': 'DRUG', 'description': '2 spray in each nostril twice daily for 14 days', 'armGroupLabels': ['GOM-NS']}, {'name': 'GMM-2 NS', 'type': 'DRUG', 'description': '2 spray in each nostril twice daily for 14 days', 'armGroupLabels': ['GMM-2 NS']}, {'name': 'GSP 301 placebo NS', 'type': 'DRUG', 'description': '2 spray 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 406', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site 414', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site 435', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site 420', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site 444', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site 428', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site 412', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site 436', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'South Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site 432', 'geoPoint': {'lat': 41.59177, 'lon': -70.94115}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site 426', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site 403', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site 443', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'city': 'Rolla', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site 441', 'geoPoint': {'lat': 37.95143, 'lon': -91.77127}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site 440', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site 405', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'city': 'Skillman', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site 434', 'geoPoint': {'lat': 40.42011, 'lon': -74.7146}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site 408', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site 418', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site 402', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site 427', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site 419', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'United States 404', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'United States 407', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site 410', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site 424', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site 411', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site 416', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 415', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 442', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Boerne', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 417', 'geoPoint': {'lat': 29.79466, 'lon': -98.73197}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 421', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 430', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 431', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'city': 'Kerrville', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 433', 'geoPoint': {'lat': 30.04743, 'lon': -99.14032}}, {'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 422', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 401', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 413', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 425', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 437', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 400', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site 409', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site 423', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'city': 'Greenfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigational Site 439', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}], 'overallOfficials': [{'name': 'Sudeesh Tantry, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glenmark Pharmaceuticals Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glenmark Specialty S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}