[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100203746":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":51,"centralContacts":42,"locations":55,"responsibleParty":96,"collaborators":42,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":42,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":42,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":119,"whyStopped":42,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,16,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm HFP","EXPERIMENTAL","1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode 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Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid",[13,14,15],[37,43,47],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Talcid (Hydrotalcite, BAY4516H)","2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine",[21,25,9,17,33,29],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Famotidine","2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg",[21,25,9,17,33,29],{"type":38,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Placebo","2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine",[21,25,9,17,33,29],[52],{"name":53,"affiliation":5,"role":54},"Bayer Study Director","STUDY_DIRECTOR",[56,68,77,85,94],{"facility":42,"status":42,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":42},"Frankfurt am Main","Hesse","60596","Germany","DE",{"type":63,"coordinates":64},"Point",[65,66],8.68417,50.11552,{"lat":66,"lon":65},{"facility":42,"status":42,"city":69,"state":70,"zip":71,"country":60,"countryCode":61,"cosmosGeoPoint":72,"geoPoint":76,"contacts":42},"Dresden","Saxony","01307",{"type":63,"coordinates":73},[74,75],13.73832,51.05089,{"lat":75,"lon":74},{"facility":42,"status":42,"city":78,"state":70,"zip":79,"country":60,"countryCode":61,"cosmosGeoPoint":80,"geoPoint":84,"contacts":42},"Leipzig","04107",{"type":63,"coordinates":81},[82,83],12.37129,51.33962,{"lat":83,"lon":82},{"facility":42,"status":42,"city":86,"state":87,"zip":88,"country":60,"countryCode":61,"cosmosGeoPoint":89,"geoPoint":93,"contacts":42},"Berlin","State of Berlin","10437",{"type":63,"coordinates":90},[91,92],13.41053,52.52437,{"lat":92,"lon":91},{"facility":42,"status":42,"city":95,"state":42,"zip":42,"country":60,"countryCode":61,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"Ask Central Contact",{"type":97,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100203746","phase-4-placebo-controlled-phase-iv-study-to-compare-the-efficacy-and-safety-of-a-single-dose-of-oral-talcid-a-single-dose-of-oral-famotidine-and-a-single-dose-of-placebo-in-patients-with-acute-heartburn-episodes-100203746",false,"NCT01928888","Placebo Controlled Phase IV Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid, a Single Dose of Oral Famotidine and a Single Dose of Placebo in Patients With Acute Heartburn Episodes","A Randomized, Double-blind, Three-fold Cross-over, Multi-center Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid (1000 mg Hydrotalcite), a Single Dose of Oral Famotidine 10 mg, and a Single Dose of Placebo in Patients With Acute Heartburn Episodes.","Inclusion Criteria:\n\n* Male or female between the age of 18 to 65 years\n* A minimum of 6 months history of heartburn\n* History of relief of heartburn episodes after self-medication (OTC use) within at least 2 hours\n* Occurrence of heartburn episodes at least twice a week during the previous two months\n* Severity of heartburn episodes at least 5 on an 11-category heartburn severity scale\n\nExclusion Criteria:\n\n* History of 'alarming symptoms' e.g. weight loss, vomiting, dysphagia, anemia, hematemesis or melaena\n* History of gastric ulcer or gastroesophageal reflux disease requiring regular or intermittent therapy with H2-antagonists or proton pump inhibitors within the previous year\n* History of significant gastrointestinal hemorrhage or gastrointestinal surgery\n* Gastrointestinal odynophagia (pain during swallowing)\n* History or concurrent known duodenitis, pyloric dysfunction with alkaline reflux, motility disturbances, Heliobacter pylori gastritis, or cholelithiasis\n* Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception","ALL","18 Years","65 Years",{"count":109,"type":110},559,"ACTUAL","INTERVENTIONAL",[113],"PHASE4","The purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn episodes. The study is designed to collect more efficacy data on Talcid® in patients using self-medication to relief the symptoms of acute heartburn.",[116],"Heartburn",[118],"Acute heartburn episodes","COMPLETED","2014-12-23",{"date":122,"type":123},"2014-12-25","ESTIMATED",{"date":125,"type":42},"2003-05",{"date":127,"type":110},"2004-02",{"name":5,"class":6},5]