[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100269528":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":38,"responsibleParty":76,"collaborators":37,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":37,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":102,"whyStopped":103,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"bismuth tripotassium dicitrate and pantoprazole","EXPERIMENTAL","Participants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets",[13,14],"Drug: bismuth tripotassium dicitrate","Drug: pantoprazole",{"label":16,"type":17,"description":18,"interventionNames":19},"pantoprazole","ACTIVE_COMPARATOR","Participants will receive pantoprazole (once daily) as single tablet",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","bismuth tripotassium dicitrate","oral",[9],[27],"De-Nol",{"type":22,"name":16,"description":24,"armGroupLabels":29,"otherNames":30},[9,16],[31],"Controloc",[33],{"name":34,"affiliation":35,"role":36},"Medical Monitor","Astellas Pharma Russian affiliate","STUDY_DIRECTOR",null,[39,50,58,63,71],{"facility":40,"status":37,"city":41,"state":37,"zip":37,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":37},"Site RU70001","Moscow","Russia","RU",{"type":45,"coordinates":46},"Point",[47,48],37.61781,55.75204,{"lat":48,"lon":47},{"facility":51,"status":37,"city":52,"state":37,"zip":37,"country":42,"countryCode":43,"cosmosGeoPoint":53,"geoPoint":57,"contacts":37},"Site RU70008","Saint Petersburg",{"type":45,"coordinates":54},[55,56],30.31413,59.93863,{"lat":56,"lon":55},{"facility":59,"status":37,"city":52,"state":37,"zip":37,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":62,"contacts":37},"Site RU70012",{"type":45,"coordinates":61},[55,56],{"lat":56,"lon":55},{"facility":64,"status":37,"city":65,"state":37,"zip":37,"country":42,"countryCode":43,"cosmosGeoPoint":66,"geoPoint":70,"contacts":37},"Site RU70006","Volgograd",{"type":45,"coordinates":67},[68,69],44.4976,48.71378,{"lat":69,"lon":68},{"facility":72,"status":37,"city":65,"state":37,"zip":37,"country":42,"countryCode":43,"cosmosGeoPoint":73,"geoPoint":75,"contacts":37},"Site RU70013",{"type":45,"coordinates":74},[68,69],{"lat":69,"lon":68},{"type":77,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100269528","phase-4-a-study-to-assess-the-efficacy-and-safety-of-bismuth-tripotassium-dicitrate-de-nol-in-combination-with-pantoprazole-and-pantoprazole-monotherapy-in-treatment-of-subjects-with-nonsteroidal-anti-inflammatory-drugs-nsaid-induced-gastropathy-100269528",false,"NCT02788123","A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Subjects With Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Induced Gastropathy","Phase IV, Multicenter, Open Label, Randomized Study in Parallel Groups To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol®) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Patients With NSAID Induced Gastropathy","BiGARD","Inclusion Criteria:\n\n* Verified diagnosis of NSAID-induced gastropathy:\n\n  * Presence of gastric ulcer(s) and\u002For erosions (modified Lanza score greater than or equal to 5) based on EGDS findings at screening and;\n  * NSAIDs administration within 7 days before screening.\n* Negative pregnancy test at screening and at Visit 1 (for females only using test strip to detect chorionic gonadotropin in urine),\n* Subjects' consent to use a reliable contraception method starting from screening throughout the whole study and for 1 week after its termination.\n\nExclusion Criteria:\n\n* Severe complications of NSAID-gastropathy (bleedings, perforations, etc.)\n* The subjects requiring concomitant therapy using the drugs specified in \"Forbidden concomitant therapy\".\n* Ulcerative esophagitis grade C and higher according to Los-Angeles classification.\n* Expressed hepatic and renal impairment.\n* Any esophageal and gastric surgery that can make subject ineligible for study participation.\n* Abuse of psychoactive substances including alcohol which may interfere with the subject's participation and fulfillment of all the protocol requirements.\n* Participation in other clinical studies within 30 days prior to Screening Visit.\n* Administration of bismuth products less than 2 months prior to screening.\n* Administration of PPIs or histamine Н2-receptor antagonists less than 2 weeks prior to screening.\n* Hypersensitivity to any of the components of the study drugs or contraindications to them.\n* Pregnancy and lactation.\n* Inability to perform follow-up EGDS after 2 and\u002For 4 weeks of the study.\n* Any condition or concomitant disease and laboratory parameter abnormalities which renders the subject ineligible for the study.","ALL","18 Years","75 Years",{"count":90,"type":91},9,"ACTUAL","INTERVENTIONAL",[94],"PHASE4","The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in subjects with NSAID-induced gastropathy in 14±2 days of treatment.",[97],"NSAID-induced Gastropathy",[27,99,100,101,42],"NSAID-induced gastropathy","Pantoprazole","Bismuth tripotassium dicitrate","TERMINATED","Internal reassessment of the medicinal product development strategy by Sponsor","2017-09-19",{"date":106,"type":91},"2017-09-21",{"date":108,"type":91},"2017-03-03",{"date":110,"type":91},"2017-06-13",{"name":112,"class":6},"Astellas Pharma Europe B.V.",5]