[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100319878":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":49,"centralContacts":39,"locations":54,"responsibleParty":68,"collaborators":39,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":39,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":92,"whyStopped":39,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Glenmark Pharmaceuticals Ltd. India","INDUSTRY",[8,14,20,25,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo nasal spray","PLACEBO_COMPARATOR","Placebo nasal spray - 2 sprays per nostril, BID",[13],"Drug: Placebo nasal spray",{"label":15,"type":16,"description":17,"interventionNames":18},"Molo 1 (also referred as GSP 301-2 NS)","EXPERIMENTAL","Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg nasal spray) - 2 sprays per nostril, BID",[19],"Drug: Molo 1 (also referred as GSP 301-2 NS)",{"label":21,"type":16,"description":22,"interventionNames":23},"Molo 2 (also referred as GSP 301-1 NS)","Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 50 mcg nasal spray) - 2 sprays per nostril, QD",[24],"Drug: Molo 2 (also referred as GSP 301-1 NS)",{"label":26,"type":27,"description":28,"interventionNames":29},"DYMISTA nasal spray","ACTIVE_COMPARATOR","Fixed Dose Combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg nasal spray - 1 spray per nostril, BID",[30],"Drug: DYMISTA nasal spray",{"label":32,"type":27,"description":33,"interventionNames":34},"PATANASE nasal spray","Olopatadine hydrochloride 665 mcg nasal spray - 2 sprays per nostril, BID",[35],"Drug: PATANASE nasal spray",[37,41,43,45,47],{"type":38,"name":15,"description":39,"armGroupLabels":40,"otherNames":39},"DRUG",null,[15],{"type":38,"name":21,"description":39,"armGroupLabels":42,"otherNames":39},[21],{"type":38,"name":9,"description":39,"armGroupLabels":44,"otherNames":39},[9],{"type":38,"name":26,"description":39,"armGroupLabels":46,"otherNames":39},[26],{"type":38,"name":32,"description":39,"armGroupLabels":48,"otherNames":39},[32],[50],{"name":51,"affiliation":52,"role":53},"Sudeesh Tantry, PhD","Glenmark Pharmaceuticals","STUDY_DIRECTOR",[55],{"facility":56,"status":39,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":39},"Glenmark Investigational Site 1","Mississauga","Ontario","L4W 1V7","Canada","CA",{"type":63,"coordinates":64},"Point",[65,66],-79.6583,43.5789,{"lat":66,"lon":65},{"type":69,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100319878","phase-2-efficacy-and-safety-of-fixed-dose-combination-fdc-of-olopatadine-hydrochloride-and-mometasone-furoate-nasal-spray-molo-also-referred-as-gsp-301-in-the-treatment-of-seasonal-allergic-rhinitis-sar-100319878",false,"NCT03444506","Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)","A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray as Compared to the FDC of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Olopatadine Nasal Spray, and Placebo in Patients With Seasonal Allergic Rhinitis.","GSP 301- PoC","Inclusion Criteria:\n\n* Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patients with known hypersensitivity to any of the components of the formulation\n* Patients with a history of seasonal asthma during ragweed season.\n* Patient requiring chronic use of inhaled or systemic corticosteroids\n* Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening\n* Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator.\n* Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy.","ALL","18 Years","65 Years",{"count":82,"type":83},180,"ACTUAL","INTERVENTIONAL",[86],"PHASE2","A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®.",[89],"Seasonal Allergic Rhinitis",[91],"SAR","COMPLETED","2018-06-18",{"date":95,"type":83},"2018-06-20",{"date":97,"type":83},"2014-01-27",{"date":99,"type":83},"2014-02-28",{"name":5,"class":6},1]