[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577588":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":72,"collaborators":74,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":11,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":113,"whyStopped":11,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Swiss Tropical & Public Health Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Emodepside","EXPERIMENTAL",null,[13,14],"Drug: emodepside (BAY 44-4400)","Drug: similar placebo to mebendazole",{"label":16,"type":17,"description":11,"interventionNames":18},"Mebendazole","ACTIVE_COMPARATOR",[19,20],"Drug: Mebendazole 100 MG","Drug: matching placebo of emodepside",[22,27,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","emodepside (BAY 44-4400)","Treatment with single dose of oral 15 mg emodepside",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Mebendazole 100 MG","Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days",[16],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"similar placebo to mebendazole","Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days",[9],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"matching placebo of emodepside","Treatment with single dose of oral emodepside matching placebo",[16],[40],{"name":41,"affiliation":5,"role":42},"Jennifer Keiser, Professor","STUDY_DIRECTOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":11,"email":47},"CONTACT","+41 61 284 82 18","jennifer.keiser@swisstph.ch",[49],{"facility":50,"status":11,"city":51,"state":11,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Siargao Island Medical Center","Dapa","Philippines","PH",{"type":55,"coordinates":56},"Point",[57,58],126.05164,9.75606,{"lat":58,"lon":57},[61,66,70],{"name":62,"role":45,"phone":63,"phoneExt":64,"email":65},"Ma. Cecilia D. Alinea, Clinical Associate Professor","+63 285448400","2100","mdalinea@up.edu.ph",{"name":67,"role":45,"phone":68,"phoneExt":11,"email":69},"Vicente Belizario Jr., Adjunct Research Professor","(+63) 917 5261359","vybelizario@up.edu.ph",{"name":62,"role":71,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[75,78,80],{"name":76,"class":77},"Bayer","INDUSTRY",{"name":79,"class":6},"Silicon Valley Community Foundation",{"name":81,"class":6},"University of the Philippines","100577588","phase-3-efficacy-and-safety-of-emodepside-in-participants-with-soil-transmitted-helminth-infections-100577588",false,"NCT06800248","Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections","A Phase III Single-center, Randomized, Double-Blinded, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of Emodepside Compared to Multiple Doses of Mebendazole in Adolescent and Adult Participants With Soil-transmitted Helminthiasis","TREMO-Siargao","Inclusion Criteria:\n\n1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.\n2. T. trichiura as a single infection or co-infection with hookworm and\u002For A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).\n3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.\n4. Written informed consent signed by the participant and\u002For legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.\n5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.\n\nExclusion Criteria:\n\n1. Presence of any systemic illnesses, renal and\u002For hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and\u002For pharmacokinetic (PK) evaluation of the study drug.\n2. Any of the following:\n\n   1. Platelet \\\u003C75,000\u002Fmm3\n   2. Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \\>3x upper limit of normal (ULN)\n   3. Total bilirubin \\>2xULN\n   4. Estimated Glomerular Filtration Rate (eGFR) \\\u003C90 ml\u002Fmin\u002F1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \\\u003C90 ml\u002F min (adults)\n3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.\n4. Use of sensitive CYP3A4 substrates within 14 days before the start of the first study intervention and until at least 14 days after the last administration of study intervention.\n5. Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention.\n6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).\n7. Known allergy\u002Fhypersensitivity to mebendazole and\u002For emodepside","ALL","12 Years",{"count":93,"type":94},315,"ESTIMATED","INTERVENTIONAL",[97],"PHASE3","This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and\u002For A. lumbricoides.",[100,101,102],"Trichuris Trichiura; Infection","Hookworm Infection","Ascaris Lumbricoides Infection",[104,105,106,107,108,109,9,110,111,112,16],"Trichuris trichiura","Ascaris lumbricoides","STH","Efficacy","Safety","Hookworm","Soil-transmitted helminths","Roundworm","Whipworm","NOT_YET_RECRUITING","2026-06-10",{"date":116,"type":117},"2026-06-11","ACTUAL",{"date":119,"type":94},"2026-09",{"date":121,"type":94},"2027-08",{"name":5,"class":6},1]