[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557888":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":51,"studyPopulation":25,"armGroups":52,"interventions":65,"overallOfficials":25,"centralContacts":73,"locations":25,"responsibleParty":83,"collaborators":25,"id":85,"slug":25,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":25,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":25,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":25,"overallStatus":103,"whyStopped":25,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":25},{"fullName":5,"class":6},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Complete response (CR) rates over 24 hours after the end of surgery","Complete response (defined as no emetic episodes and no use of rescue therapy)","0-24 hours after the end of surgery",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery","No nausea（defined as a visual analogue scale (VAS) nausea score \\\u003C 1.）",{"measure":18,"description":19,"timeFrame":12},"Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery","Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4）",{"measure":21,"description":22,"timeFrame":12},"Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery","No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）",{"measure":24,"description":25,"timeFrame":12},"Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery",null,{"measure":27,"description":28,"timeFrame":12},"Time to treatment failure in the 0 to 24 hours following the end of surgery","defined as the time to the first episode of vomiting (vomiting or retching) or the time to rescue therapy, whichever occurred first.",{"measure":30,"description":22,"timeFrame":31},"Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery","0-48 hours after the end of surgery",{"measure":33,"description":25,"timeFrame":31},"The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery",[35],{"measure":36,"description":37,"timeFrame":38},"Number of participants with treatment-related adverse events as assessed by NIH","Safety was assessed by Adverse events (AEs) were recorded after administration.","Day 0 to Day14",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":25,"timePerspective":25,"maskingInfo":44},"RANDOMIZED","PARALLEL","Parrallel Assignment","TREATMENT",{"masking":45,"maskingDescription":25,"whoMasked":46},"QUADRUPLE",[47,48,49,50],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Aprepitant Injection","EXPERIMENTAL","Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds",[58],"Drug: Aprepitant Injection",{"label":60,"type":61,"description":62,"interventionNames":63},"Placebo","PLACEBO_COMPARATOR","Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds",[64],"Drug: Aprepitant Injection Placebo",[66,69],{"type":67,"name":54,"description":56,"armGroupLabels":68,"otherNames":25},"DRUG",[54],{"type":67,"name":70,"description":71,"armGroupLabels":72,"otherNames":25},"Aprepitant Injection Placebo","Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds",[60],[74,79],{"name":75,"role":76,"phone":77,"phoneExt":25,"email":78},"xiangdong chen, Doctor of Medicine(M.D.)","CONTACT","+86-027-85726300","xiangdongchen2013@163.com",{"name":80,"role":76,"phone":81,"phoneExt":25,"email":82},"Clinical Trials Information Group officer","86-0311-69085587","ctr-contact@cspc.cn",{"type":84,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100557888",false,"NCT06543966","Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting","A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection in the Prevention of Post-operative Nausea and Vomiting","Inclusion Criteria:\n\nAge ≥18 and ≤75 years old; 18 \\\u003C BMI≤30kg\u002Fm\\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.\n\nexpected or agreed to stay in the hospital for 24 hours or more after surgery;\n\nExclusion Criteria:\n\ndiagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;","ALL","18 Years","75 Years",{"count":95,"type":96},486,"ESTIMATED","INTERVENTIONAL",[99],"PHASE3","A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,",[102],"Post-operative Nausea and Vomiting (PONV)","NOT_YET_RECRUITING","2024-08-05",{"date":106,"type":107},"2024-08-09","ACTUAL",{"date":109,"type":96},"2024-10-28",{"date":111,"type":96},"2026-03-28",{"name":5,"class":6}]