[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595697":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":46,"collaborators":25,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":25,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Shanghai Children's Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Olanzapine group","EXPERIMENTAL","Oral olanzapine tablets",[13],"Drug: Olanzapine Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Oral placebo",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Olanzapine Tablets",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Placebo",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Liting Yu","CONTACT","13636303912","yuliting20091396@163.com",[36],{"facility":5,"status":25,"city":37,"state":25,"zip":25,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":25},"Shanghai","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},{"type":47,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100595697","phase-3-olanzapine-for-prevention-of-vomiting-in-children-and-adolescents-receiving-highly-emetogenic-chemotherapy-100595697",false,"NCT07035821","Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy","Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial","Inclusion Criteria:\n\n\\- The major inclusion criteria were children aged 5 to 18 years at the time of study entry with documented cancer; receiving NK-1 inhibitor (aprepitant\u002Ffosaprepitant) and 5HT-3 antagonist (ondansetron) and\u002For dexamethasone as prophylactic antiemetics for CINV due to MEC or HEC; minimum body weight of 10 kg; development of breakthrough vomiting after starting prophylactic antiemetics; Lansky performance scale of above 50 (for patients aged 10 years or less) or Eastern Cooperative Oncology Group performance scale less than 3 and normal electrocardiogram (ECG) before the initiation of the prophylactic antiemetics.\n\nExclusion Criteria:\n\n* Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.","ALL","5 Years","18 Years",{"count":59,"type":60},100,"ESTIMATED","INTERVENTIONAL",[63],"PHASE3","Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.",[66,67],"Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients","Pediatric Cancer",[69,70,71,72],"chemotherapy","olanzapine","pediatric cancer","vomiting","NOT_YET_RECRUITING","2025-06-16",{"date":76,"type":77},"2025-06-25","ACTUAL",{"date":79,"type":60},"2025-07-01",{"date":81,"type":60},"2026-07-30",{"name":5,"class":6},1]