[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100197252":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":28,"responsibleParty":114,"collaborators":11,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":11,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":11,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":11,"overallStatus":136,"whyStopped":11,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Materia Medica Holding","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ergoferon (5 ml 3 times a day)","EXPERIMENTAL",null,[13],"Drug: Ergoferon",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo (5 ml 3 times a day)","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Ergoferon","Safety and Efficiency of liquid dosage form",[9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"Placebo",[15],[29,41,50,59,63,72,78,84,90,96,105],{"facility":30,"status":11,"city":31,"state":11,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":11},"State Educational Institution of Higher Professional Education \"Moscow State Medical Academy named after I.M. Sechenov\"","Moscow","119992","Russia","RU",{"type":36,"coordinates":37},"Point",[38,39],37.61781,55.75204,{"lat":39,"lon":38},{"facility":42,"status":11,"city":43,"state":11,"zip":44,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":49,"contacts":11},"State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation","Novosibirsk","630091",{"type":36,"coordinates":46},[47,48],82.93175,55.02259,{"lat":48,"lon":47},{"facility":51,"status":11,"city":52,"state":11,"zip":53,"country":33,"countryCode":34,"cosmosGeoPoint":54,"geoPoint":58,"contacts":11},"Municipal Health Care Institution \"City Child Health Clinical Polyclinic №5\"","Perm","614066",{"type":36,"coordinates":55},[56,57],56.25017,58.01046,{"lat":57,"lon":56},{"facility":60,"status":11,"city":61,"state":11,"zip":62,"country":33,"countryCode":34,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"St. Peterburg State Health Care Institution \"Child Health City Hospital №45 of the Nevsky Region\"","Saint Peterburg","193312",{"facility":64,"status":11,"city":65,"state":11,"zip":66,"country":33,"countryCode":34,"cosmosGeoPoint":67,"geoPoint":71,"contacts":11},"State Budgetary Health Care Institution \"Сity Child Health Polyclinic №44\"","Saint Petersburg","191144",{"type":36,"coordinates":68},[69,70],30.31413,59.93863,{"lat":70,"lon":69},{"facility":73,"status":11,"city":65,"state":11,"zip":74,"country":33,"countryCode":34,"cosmosGeoPoint":75,"geoPoint":77,"contacts":11},"St. Petersburg State Budgetary Health Care Institution \"Сity Polyclinic №44\"","192212",{"type":36,"coordinates":76},[69,70],{"lat":70,"lon":69},{"facility":79,"status":11,"city":65,"state":11,"zip":80,"country":33,"countryCode":34,"cosmosGeoPoint":81,"geoPoint":83,"contacts":11},"State Budgetary Educational Institution of Higher Professional Education \"St. Petersburg State Pediatric Medical Academy\" of Ministry of Health of Russian Federation","194100",{"type":36,"coordinates":82},[69,70],{"lat":70,"lon":69},{"facility":85,"status":11,"city":65,"state":11,"zip":86,"country":33,"countryCode":34,"cosmosGeoPoint":87,"geoPoint":89,"contacts":11},"Limited Liability Company \"Alliance Biomedical-Russian group\"","194356",{"type":36,"coordinates":88},[69,70],{"lat":70,"lon":69},{"facility":91,"status":11,"city":65,"state":11,"zip":92,"country":33,"countryCode":34,"cosmosGeoPoint":93,"geoPoint":95,"contacts":11},"State Health Care Institution \"Child Health City Hospital №22\"","196650",{"type":36,"coordinates":94},[69,70],{"lat":70,"lon":69},{"facility":97,"status":11,"city":98,"state":11,"zip":99,"country":33,"countryCode":34,"cosmosGeoPoint":100,"geoPoint":104,"contacts":11},"State Budgetary Educational Institution of Higher Professional Education \" Yaroslavl State Medical Academy\" of Ministry of Health","Yaroslavl","150000",{"type":36,"coordinates":101},[102,103],39.87368,57.62987,{"lat":103,"lon":102},{"facility":106,"status":11,"city":107,"state":11,"zip":108,"country":33,"countryCode":34,"cosmosGeoPoint":109,"geoPoint":113,"contacts":11},"Municipal Institution \"Child Health City Hospital №11\"","Yekaterinburg","620028",{"type":36,"coordinates":110},[111,112],60.61529,56.85733,{"lat":112,"lon":111},{"type":115,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100197252","phase-3-clinical-trial-of-safety-and-clinical-efficacy-of-ergoferon-in-liquid-dosage-form-in-treatment-of-acute-upper-respiratory-tract-infections-in-children-100197252",true,"NCT01843842","Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children","Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children","Inclusion Criteria:\n\n1. Patients of both sexes aged over 3 years and under 18 years.\n2. Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal\u002F throat\u002F chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity.\n3. The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.\n4. Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.\n5. Availability of information sheet (Informed Consent form) for parents\u002Fadopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent\u002Fadopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent\u002Fadopter of patient.\n\nExclusion Criteria:\n\n1. Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).\n2. Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).\n3. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and \u002For B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.\n4. Medical history of sarcoidosis.\n5. Oncological diseases.\n6. Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.\n7. Medical history of polyvalent allergy.\n8. Allergy\u002F intolerance to any of the components of medications used in the treatment.\n9. Impaired glucose tolerance, diabetes mellitus.\n10. Hereditary fructose intolerance (as the study drug contains maltitol).\n11. Intake of medicines listed in the section \"Prohibited concomitant treatment\" for 1 month prior to the inclusion in the trial.\n12. Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.\n13. Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents\u002Fadopters.\n14. Mental disorders of patient or of patient's parents\u002Fadopters.\n15. Patient's parents\u002F adopters, who from investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.\n16. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.\n17. Patient's parent\u002Fadopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband\u002Fwife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.\n18. Patient's parent\u002Fadopter works for OOO \"NPF \"Materia Medica Holding\" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.",false,"ALL","3 Years","18 Years",{"count":128,"type":129},306,"ACTUAL","INTERVENTIONAL",[132],"PHASE3","The purpose of this study is:\n\n* to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children;\n* to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.",[135],"Acute Upper Respiratory Tract Infections","COMPLETED","2018-11-28",{"date":139,"type":129},"2018-11-29",{"date":141,"type":11},"2013-04",{"date":143,"type":129},"2015-03",{"name":5,"class":6},11]