Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02318303
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2014-12-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}]}}, '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 CRO/ Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact', 'eventGroups': [{'id': 'EG000', 'title': 'GSP 301 Placebo NS', 'description': 'GSP 301 placebo NS administered as 2 sprays/nostril', 'otherNumAtRisk': 159, 'otherNumAffected': 0, 'seriousNumAtRisk': 159, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GSP 301-1 NS (QD)', 'description': 'GSP 301-1 NS (QD) administered as 2 sprays/nostril', 'otherNumAtRisk': 158, 'otherNumAffected': 0, 'seriousNumAtRisk': 158, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Mometasone Furoate-1 NS (QD)', 'description': 'Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril', 'otherNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Olopatadine HCl-1 NS (QD)', 'description': 'Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril', 'otherNumAtRisk': 158, 'otherNumAffected': 0, 'seriousNumAtRisk': 158, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'GSP 301-2 NS (BID)', 'description': 'GSP 301-2 NS (BID) administered as 2 sprays/nostril.', 'otherNumAtRisk': 157, 'otherNumAffected': 0, 'seriousNumAtRisk': 157, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Mometasone Furoate-2 NS (BID)', 'description': 'Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril', 'otherNumAtRisk': 159, 'otherNumAffected': 0, 'seriousNumAtRisk': 159, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Olopatadine HCl-2 NS (BID)', 'description': 'Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril', 'otherNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Gastrointestinal ulcer and Gastritis', 'notes': 'There were two SAEs (gastrointestinal ulcer and gastritis) reported both in the same subject.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in rTNSS From Baseline to End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '158', 'groupId': 'OG003'}, {'value': '157', 'groupId': 'OG004'}, {'value': '159', 'groupId': 'OG005'}, {'value': '160', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'GSP 301 Placebo', 'description': 'GSP 301 placebo NS administered as 2 sprays/nostril'}, {'id': 'OG001', 'title': 'GSP 301-1 NS (QD)', 'description': 'GSP 301-1 NS (QD) administered as 2 sprays/nostril'}, {'id': 'OG002', 'title': 'Mometasone Furoate-1 NS (QD)', 'description': 'Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril'}, {'id': 'OG003', 'title': 'Olopatadine HCl-1 NS (QD)', 'description': 'Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril'}, {'id': 'OG004', 'title': 'GSP 301-2 NS (BID)', 'description': 'GSP 301-2 NS (BID) administered as 2 sprays/nostril'}, {'id': 'OG005', 'title': 'Mometasone Furoate-2 NS (BID)', 'description': 'Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril'}, {'id': 'OG006', 'title': 'Olopatadine HCl-2 NS (BID)', 'description': 'Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.3', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '1.30', 'groupId': 'OG002'}, {'value': '10.3', 'spread': '1.26', 'groupId': 'OG003'}, {'value': '10.4', 'spread': '1.19', 'groupId': 'OG004'}, {'value': '10.5', 'spread': '1.13', 'groupId': 'OG005'}, {'value': '10.3', 'spread': '1.24', 'groupId': 'OG006'}]}]}, {'title': 'Change from Baseline to Visit 4', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '2.68', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '2.09', 'groupId': 'OG003'}, {'value': '-2.6', 'spread': '2.56', 'groupId': 'OG004'}, {'value': '-1.9', 'spread': '1.88', 'groupId': 'OG005'}, {'value': '-2.1', 'spread': '2.26', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.1087', 'ciLowerLimit': '-1.6690', 'ciUpperLimit': '-0.5485', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.1703', 'ciLowerLimit': '-1.7315', 'ciUpperLimit': '-0.6090', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0020', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7718', 'ciLowerLimit': '-1.2616', 'ciUpperLimit': '-0.2820', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1524', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3563', 'ciLowerLimit': '-0.8445', 'ciUpperLimit': '0.1319', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0488', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4918', 'ciLowerLimit': '-0.9810', 'ciUpperLimit': '-0.0025', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0043', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7133', 'ciLowerLimit': '-1.2031', 'ciUpperLimit': '-0.2235', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.\n\nThe total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome.\n\nThe severity scale for each symptom evaluation was defined as follows:\n\n* 0 = absent (no sign/symptom evident)\n* 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)\n* 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)\n* 3 = severe (sign/symptom that is hard to tolerate \\[i.e., causes interference with activities of daily living and/or sleeping\\])', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized subjects who received at least one dose of randomized study medication 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': 'GSP 301 placebo NS administered as 2 sprays/nostril'}, {'id': 'FG001', 'title': 'GSP 301-1 NS (QD)', 'description': 'GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril'}, {'id': 'FG002', 'title': 'Mometasone Furoate-1 NS (QD)', 'description': 'Mometasone furoate-1 NS (50 μg) administered as 2 sprays/nostril'}, {'id': 'FG003', 'title': 'Olopatadine HCl-1 NS (QD)', 'description': 'Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril'}, {'id': 'FG004', 'title': 'GSP 301-2 NS (BID)', 'description': 'GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril'}, {'id': 'FG005', 'title': 'Mometasone Furoate-2 NS (BID)', 'description': 'Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril'}, {'id': 'FG006', 'title': 'Olopatadine HCl-2 NS (BID)', 'description': 'Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '158'}, {'groupId': 'FG004', 'numSubjects': '157'}, {'groupId': 'FG005', 'numSubjects': '159'}, {'groupId': 'FG006', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '157'}, {'groupId': 'FG003', 'numSubjects': '155'}, {'groupId': 'FG004', 'numSubjects': '152'}, {'groupId': 'FG005', 'numSubjects': '153'}, {'groupId': 'FG006', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at 10 sites in the US.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}, {'value': '159', 'groupId': 'BG005'}, {'value': '160', 'groupId': 'BG006'}, {'value': '1111', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'GSP 301 Placebo NS', 'description': 'GSP 301 placebo NS administered as 2 sprays/nostril'}, {'id': 'BG001', 'title': 'GSP 301-1 NS (QD)', 'description': 'GSP 301-1 NS administered as 2 sprays/nostril'}, {'id': 'BG002', 'title': 'Mometasone Furoate-1 NS (QD)', 'description': 'Mometasone furoate-1 NS administered as 2 sprays/nostril'}, {'id': 'BG003', 'title': 'Olopatadine HCl-1 NS (QD)', 'description': 'Olopatadine HCl-1 NS administered as 2 sprays/nostril'}, {'id': 'BG004', 'title': 'GSP 301-2 NS (BID)', 'description': 'GSP 301-2 NS administered as 2 sprays/nostril'}, {'id': 'BG005', 'title': 'Mometasone Furoate-2 NS (BID)', 'description': 'Mometasone furoate-2 NS administered as 2 sprays/nostril'}, {'id': 'BG006', 'title': 'Olopatadine HCl-2 NS (BID)', 'description': 'Olopatadine HCl-2 NS administered as 2 sprays/nostril'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.35', 'spread': '14.951', 'groupId': 'BG000'}, {'value': '43.83', 'spread': '13.609', 'groupId': 'BG001'}, {'value': '44.40', 'spread': '14.312', 'groupId': 'BG002'}, {'value': '41.90', 'spread': '12.478', 'groupId': 'BG003'}, {'value': '43.44', 'spread': '14.128', 'groupId': 'BG004'}, {'value': '44.58', 'spread': '13.698', 'groupId': 'BG005'}, {'value': '43.49', 'spread': '13.868', 'groupId': 'BG006'}, {'value': '43.86', 'spread': '13.882', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}, {'value': '96', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}, {'value': '740', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}, {'value': '371', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2014-12-03', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2014-12-12', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in rTNSS From Baseline to End of Treatment', 'timeFrame': '14 days', 'description': 'Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.\n\nThe total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome.\n\nThe severity scale for each symptom evaluation was defined as follows:\n\n* 0 = absent (no sign/symptom evident)\n* 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)\n* 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)\n* 3 = severe (sign/symptom that is hard to tolerate \\[i.e., causes interference with activities of daily living and/or sleeping\\])'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '31734334', 'type': 'DERIVED', 'citation': 'Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key 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 study season for the mountain cedar 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\nKey Exclusion 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 nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.\n4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.\n5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.\n6. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.\n7. Subjects with an active pulmonary disorder or infection.\n8. Subjects with posterior subcapsular cataracts or glaucoma.'}, 'identificationModule': {'nctId': 'NCT02318303', 'briefTitle': 'To Study GSP 301 in Patients With Seasonal Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glenmark Pharmaceuticals Ltd. India'}, 'officialTitle': 'A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)', 'orgStudyIdInfo': {'id': 'GPL/CT/2014/004/II'}, 'secondaryIdInfos': [{'id': 'IND Number: 123164', 'type': 'OTHER', 'domain': 'Center for Drug Evaluation and Research (CDER)'}, {'id': 'Study Number (GSP 301-201)', 'type': 'OTHER', 'domain': 'Glenmark Pharmaceuticals Ltd.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'GSP 301 Placebo NS', 'interventionNames': ['Drug: GSP 301 Placebo NS']}, {'type': 'EXPERIMENTAL', 'label': 'GSP 301-1 NS (QD)', 'interventionNames': ['Drug: GSP 301-1 NS (QD)']}, {'type': 'EXPERIMENTAL', 'label': 'GSP 301-2 NS (BID)', 'interventionNames': ['Drug: GSP 301-2 NS (BID)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olopatadine HCl-1 NS (QD)', 'interventionNames': ['Drug: Olopatadine HCl-1 NS (QD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olopatadine HCl-2 NS (BID)', 'interventionNames': ['Drug: Olopatadine HCl-2 NS (BID)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mometasone Furoate-1 NS (QD)', 'interventionNames': ['Drug: Mometasone Furoate-1 NS (QD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mometasone Furoate-2 NS (BID)', 'interventionNames': ['Drug: Mometasone Furoate-2 NS (BID)']}], 'interventions': [{'name': 'GSP 301-1 NS (QD)', 'type': 'DRUG', 'description': 'GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril', 'armGroupLabels': ['GSP 301-1 NS (QD)']}, {'name': 'GSP 301-2 NS (BID)', 'type': 'DRUG', 'description': 'GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril', 'armGroupLabels': ['GSP 301-2 NS (BID)']}, {'name': 'GSP 301 Placebo NS', 'type': 'DRUG', 'description': 'GSP 301 placebo NS administered as 2 sprays/nostril', 'armGroupLabels': ['GSP 301 Placebo NS']}, {'name': 'Olopatadine HCl-1 NS (QD)', 'type': 'DRUG', 'description': 'Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril', 'armGroupLabels': ['Olopatadine HCl-1 NS (QD)']}, {'name': 'Olopatadine HCl-2 NS (BID)', 'type': 'DRUG', 'description': 'Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril', 'armGroupLabels': ['Olopatadine HCl-2 NS (BID)']}, {'name': 'Mometasone Furoate-1 NS (QD)', 'type': 'DRUG', 'description': 'Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril', 'armGroupLabels': ['Mometasone Furoate-1 NS (QD)']}, {'name': 'Mometasone Furoate-2 NS (BID)', 'type': 'DRUG', 'description': 'Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril', 'armGroupLabels': ['Mometasone Furoate-2 NS (BID)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 10', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 5', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 6', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Kerrville', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 2', 'geoPoint': {'lat': 30.04743, 'lon': -99.14032}}, {'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 7', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 3', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 4', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 8', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 9', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 1', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'overallOfficials': [{'name': 'Sudeesh Tantry, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glenmark Pharmaceuticals Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glenmark Pharmaceuticals Ltd. India', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}