[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520582":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":43,"responsibleParty":165,"collaborators":11,"id":168,"slug":169,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":11,"eligibilityCriteria":173,"healthyVolunteers":170,"sex":174,"minAge":175,"maxAge":11,"enrollmentInfo":176,"targetDuration":11,"studyType":179,"phases":180,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"University of Leipzig","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NORTASE®","EXPERIMENTAL",null,[13],"Drug: NORTASE®",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","10-15 capsules of NORTASE® per day - over 6 months",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"10-15 capsules of placebo per day - over 6 months",[15],[28],{"name":29,"affiliation":30,"role":31},"Albrecht Hoffmeister, Prof. Dr.","Universität Leipzig","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+4934197","12240","Albrecht.Hoffmeister@medizin.uni-leipzig.de",{"name":39,"role":34,"phone":40,"phoneExt":41,"email":42},"Anett Schmiedeknecht, Dr.","+49 34197","16256","anett.schmiedeknecht@zks.uni-leipzig.de",[44,61,76,89,103,117,128,138,152],{"facility":45,"status":46,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie \u002F Thoraxchirurgie","NOT_YET_RECRUITING","Borna","Germany","DE",{"type":51,"coordinates":52},"Point",[53,54],12.49639,51.12416,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":11,"email":60},"Kay Kohlhaw, PD Dr.","+49 3433 21-1501","Kay.Kohlhaw@Sana.de",{"facility":62,"status":63,"city":64,"state":11,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik","RECRUITING","Cottbus","03048",{"type":51,"coordinates":67},[68,69],14.32888,51.75769,{"lat":69,"lon":68},[72],{"name":73,"role":34,"phone":74,"phoneExt":11,"email":75},"Tobias Kleemann, Dr.","+493554679427","t.kleemann@ctk.de",{"facility":77,"status":46,"city":78,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie","Essen",{"type":51,"coordinates":80},[81,82],7.01228,51.45657,{"lat":82,"lon":81},[85],{"name":86,"role":34,"phone":87,"phoneExt":11,"email":88},"Christian Müller, Dr.","+49 201 174-24001","Ch.Mueller@kem-med.com",{"facility":90,"status":63,"city":91,"state":11,"zip":92,"country":48,"countryCode":49,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie","Freiburg im Breisgau","79106",{"type":51,"coordinates":94},[95,96],7.85222,47.9959,{"lat":96,"lon":95},[99],{"name":100,"role":34,"phone":101,"phoneExt":11,"email":102},"Jasmina Kuvendjiska, Dr.","+4976127024010","jasmina.kuvendjiska@uniklinik-freiburg.de",{"facility":104,"status":63,"city":105,"state":11,"zip":106,"country":48,"countryCode":49,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie","Jena","07740",{"type":51,"coordinates":108},[109,110],11.5899,50.92878,{"lat":110,"lon":109},[113],{"name":114,"role":34,"phone":115,"phoneExt":11,"email":116},"Michael Ardelt, PD Dr. Dr.","+4936419322675","michael.ardelt@med.uni-jena.de",{"facility":118,"status":63,"city":119,"state":11,"zip":120,"country":48,"countryCode":49,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig","Leipzig","04103",{"type":51,"coordinates":122},[123,124],12.37129,51.33962,{"lat":124,"lon":123},[127],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},{"facility":129,"status":63,"city":119,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie",{"type":51,"coordinates":131},[123,124],{"lat":124,"lon":123},[134],{"name":135,"role":34,"phone":136,"phoneExt":11,"email":137},"Boris Jansen-Winkeln, PD Dr.","+49 341 909-2200","allgemein-viszeralchirurgie@sanktgeorg.de",{"facility":139,"status":63,"city":140,"state":11,"zip":141,"country":48,"countryCode":49,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie","Schwerin","19055",{"type":51,"coordinates":143},[144,145],11.41316,53.62937,{"lat":145,"lon":144},[148],{"name":149,"role":34,"phone":150,"phoneExt":11,"email":151},"Judith Sporn, Dr.","03855205382","judith.sporn@helios-gesundheit.de",{"facility":153,"status":63,"city":154,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm","Ulm",{"type":51,"coordinates":156},[157,158],9.99155,48.39841,{"lat":158,"lon":157},[161],{"name":162,"role":34,"phone":163,"phoneExt":11,"email":164},"Patrick Téoule, PD Dr.","+49 731-5000","patrick.teoule@uniklinik-ulm.de",{"type":31,"investigatorFullName":166,"investigatorTitle":167,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Albrecht Hoffmeister","Prof. Dr. med.","100520582","phase-3-the-pancreatic-enzymes-after-gastrectomy-trial-100520582",false,"NCT06058442","The Pancreatic Enzymes After Gastrectomy Trial","Inclusion Criteria:\n\n1. Gastrectomy (total and partial); at least \\> 50 % of the stomach must be resected\n2. Age 18 or older\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Indication for pancreas enzyme therapy\n2. Gastrectomy with palliative intention\n3. UICC (Union for International Cancer Control) Stage IV gastric malignancy\n4. Malnutrition of other aetiology\n5. Life expectancy \\\u003C 12 months\n6. Known lactose intolerance\n7. Known hereditary galactose intolerance\n8. Patients on alpha-glucosidase inhibitors (AGIs)\n9. Acute pancreatitis\n10. Acute episode of chronic pancreatitis\n11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®\n12. Participation in competing interventional trials may be allowed under circumstances\n13. Patients under legal supervision or guardianship\n14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor\n15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial\n16. Pregnant or nursing women\n17. Suspected lack of compliance\n18. Patients who were already enrolled in the trial","ALL","18 Years",{"count":177,"type":178},188,"ESTIMATED","INTERVENTIONAL",[181],"PHASE3","This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.",[184],"Gastrectomy",[186,187,188,189,190],"enzyme supplementation","lipase","elastase","gastrointestinal","quality of life","2026-01-19",{"date":193,"type":194},"2026-01-22","ACTUAL",{"date":196,"type":194},"2024-01-24",{"date":198,"type":178},"2027-06",{"name":5,"class":6},9]