[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100293104":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":34,"responsibleParty":121,"collaborators":26,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":26,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":26,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":147,"whyStopped":26,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Sandoz","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Angal S (Arm A)","EXPERIMENTAL","Patients received Angal S, topical spray \\[Menthol\\], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution",[13],"Drug: Angal S, topical spray [Menthol]",{"label":15,"type":16,"description":17,"interventionNames":18},"ANTI-ANGIN® FORMULA (Arm B)","ACTIVE_COMPARATOR","Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC \"Valeant\", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution",[19],"Drug: ANTI-ANGIN® FORMULA, topical metered spray",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Angal S, topical spray [Menthol]","0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ANTI-ANGIN® FORMULA, topical metered spray","0,12 mg + 0,24 mg (LLC \"Valeant\", Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution",[15],[32],{"name":5,"affiliation":5,"role":33},"STUDY_DIRECTOR",[35,47,55,60,65,70,75,83,88,93,98,103,108,113],{"facility":36,"status":26,"city":37,"state":26,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":26},"Sandoz Investigational Site","Arkhangelsk","163000","Russia","RU",{"type":42,"coordinates":43},"Point",[44,45],40.55183,64.5461,{"lat":45,"lon":44},{"facility":36,"status":26,"city":48,"state":26,"zip":49,"country":39,"countryCode":40,"cosmosGeoPoint":50,"geoPoint":54,"contacts":26},"Moscow","105018",{"type":42,"coordinates":51},[52,53],37.61781,55.75204,{"lat":53,"lon":52},{"facility":36,"status":26,"city":48,"state":26,"zip":56,"country":39,"countryCode":40,"cosmosGeoPoint":57,"geoPoint":59,"contacts":26},"115280",{"type":42,"coordinates":58},[52,53],{"lat":53,"lon":52},{"facility":36,"status":26,"city":48,"state":26,"zip":61,"country":39,"countryCode":40,"cosmosGeoPoint":62,"geoPoint":64,"contacts":26},"119192",{"type":42,"coordinates":63},[52,53],{"lat":53,"lon":52},{"facility":36,"status":26,"city":48,"state":26,"zip":66,"country":39,"countryCode":40,"cosmosGeoPoint":67,"geoPoint":69,"contacts":26},"127015",{"type":42,"coordinates":68},[52,53],{"lat":53,"lon":52},{"facility":36,"status":26,"city":48,"state":26,"zip":71,"country":39,"countryCode":40,"cosmosGeoPoint":72,"geoPoint":74,"contacts":26},"135215",{"type":42,"coordinates":73},[52,53],{"lat":53,"lon":52},{"facility":36,"status":26,"city":76,"state":26,"zip":77,"country":39,"countryCode":40,"cosmosGeoPoint":78,"geoPoint":82,"contacts":26},"Saint Petersburg","188643",{"type":42,"coordinates":79},[80,81],30.31413,59.93863,{"lat":81,"lon":80},{"facility":36,"status":26,"city":76,"state":26,"zip":84,"country":39,"countryCode":40,"cosmosGeoPoint":85,"geoPoint":87,"contacts":26},"191036",{"type":42,"coordinates":86},[80,81],{"lat":81,"lon":80},{"facility":36,"status":26,"city":76,"state":26,"zip":89,"country":39,"countryCode":40,"cosmosGeoPoint":90,"geoPoint":92,"contacts":26},"196143",{"type":42,"coordinates":91},[80,81],{"lat":81,"lon":80},{"facility":36,"status":26,"city":76,"state":26,"zip":94,"country":39,"countryCode":40,"cosmosGeoPoint":95,"geoPoint":97,"contacts":26},"197706",{"type":42,"coordinates":96},[80,81],{"lat":81,"lon":80},{"facility":36,"status":26,"city":76,"state":26,"zip":99,"country":39,"countryCode":40,"cosmosGeoPoint":100,"geoPoint":102,"contacts":26},"198207",{"type":42,"coordinates":101},[80,81],{"lat":81,"lon":80},{"facility":36,"status":26,"city":76,"state":26,"zip":104,"country":39,"countryCode":40,"cosmosGeoPoint":105,"geoPoint":107,"contacts":26},"199178",{"type":42,"coordinates":106},[80,81],{"lat":81,"lon":80},{"facility":36,"status":26,"city":76,"state":26,"zip":109,"country":39,"countryCode":40,"cosmosGeoPoint":110,"geoPoint":112,"contacts":26},"199226",{"type":42,"coordinates":111},[80,81],{"lat":81,"lon":80},{"facility":36,"status":26,"city":114,"state":26,"zip":115,"country":39,"countryCode":40,"cosmosGeoPoint":116,"geoPoint":120,"contacts":26},"Stavropol","355000",{"type":42,"coordinates":117},[118,119],41.9642,45.03442,{"lat":119,"lon":118},{"type":122,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100293104","phase-3-clinical-study-for-comparative-assessment-of-efficacy-and-safety-of-angal-s-topical-spray-and-anti-angin-formula-topical-metered-spray-in-treatment-of-patients-with-uncomplicated-acute-infectious-and-inflammatory-diseases-of-the-pharynx-accompanied-by-a-sore-throat-100293104",true,"NCT03095508","Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat","Prospective, Multicenter, Open, Randomized, Parallel, Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray [Menthol], 0,5 mg + 2 mg \u002F 1 ml (Sandoz d.d., Slovenia), and ANTI-ANGIN® FORMULA, Topical Metered Spray, 0,12 mg + 0,24 mg \u002F Dose (OOO \"Valeant\", Russia) in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat","Inclusion Criteria:\n\n* Voluntarily signed informed consent for participation in this clinical study;\n* 18 to 45 years old inclusive, male and female;\n* Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;\n* Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and\u002For tonsillitis) less than 48 hours prior to inclusion into the study; Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5 (total score);\n* Body temperature 37,5 C (axillary).\n\nExclusion Criteria:\n\n* Use of analgesics within \\\u003C12 hours prior to the study start or\u002Fand inability to cancel them during the study;\n* Use of antibiotics within \\\u003C48 hours prior to the study start or\u002Fand inability to cancel them during the study;\n* Use of local therapy (sprays, rinses, lozenges) to pharynx within \\\u003C12 hours before study start or\u002Fand inability to cancel them, besides study medications;\n* Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means);\n* Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased ESR 30 mm\u002Fhr).",false,"ALL","18 Years","45 Years",{"count":135,"type":136},229,"ACTUAL","INTERVENTIONAL",[139],"PHASE3","The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal S, topical spray \\[Menthol\\], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC \"Valeant\", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.",[142],"Sore Throat",[144,145,142,146],"Angal S","ANTI-ANGIN FORMULA","no less therapeutic efficacy","COMPLETED","2018-12-14",{"date":150,"type":136},"2019-03-21",{"date":152,"type":136},"2017-02-22",{"date":154,"type":136},"2017-05-08",{"name":5,"class":6},14]