[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607274":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":76,"collaborators":30,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":30,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":30,"overallStatus":46,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"HSK21542","EXPERIMENTAL","Patients administrated with HSK21542",[13],"Drug: HSK21542",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo control","PLACEBO_COMPARATOR","Patients administrated with placebo",[19],"Drug: Placebo",{"label":21,"type":22,"description":23,"interventionNames":24},"Actice control","ACTIVE_COMPARATOR","Patients administrated with morphine",[25],"Drug: morphine",[27,31,34],{"type":28,"name":9,"description":11,"armGroupLabels":29,"otherNames":30},"DRUG",[9],null,{"type":28,"name":32,"description":17,"armGroupLabels":33,"otherNames":30},"Placebo",[15],{"type":28,"name":35,"description":23,"armGroupLabels":36,"otherNames":30},"morphine",[21],[38],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Jianwei Tang","CONTACT","028-67258779","tangjianw@haisco.com",[44,62],{"facility":45,"status":46,"city":47,"state":48,"zip":30,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Xuanwu Hospital Capital Medical University","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58],{"name":59,"role":40,"phone":60,"phoneExt":30,"email":61},"Tianlong Wang","139 1052 5304","w_tl5595@hotmail.com",{"facility":63,"status":46,"city":64,"state":65,"zip":30,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Xiangya Hospital of Central South University","Changsha","Hunan",{"type":52,"coordinates":67},[68,69],112.97087,28.19874,{"lat":69,"lon":68},[72],{"name":73,"role":40,"phone":74,"phoneExt":30,"email":75},"E Wang","18874889950","ewang324@csu.edu.cn",{"type":77,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100607274","phase-3-a-clinical-trial-evaluating-the-efficacy-and-safety-of-hsk21542-in-patients-for-postoperative-pain-treatment-in-orthopedic-surgery-100607274",false,"NCT07186426","A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery","A Multi-Center, Randomized, Double-Blind, Placebo\u002FActive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery","Inclusion Criteria:\n\n* 18 years old ≤ age ≤74 years old, regardless of gender;\n* 18 kg\u002Fm2≤BMI≤32 kg\u002Fm2，meet the weight range specified in the protocol；\n* American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;\n* Accept hip replacement under general anesthesia;\n* Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;\n* Fully understand and voluntarily participate this trial, and sign the informed consent form;\n\nExclusion Criteria:\n\n* Patients with allergy to opioids or any component of the trial drug；\n* Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;\n* Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety；\n* Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;\n* Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;\n* Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;\n* A history of drug, drug, and\u002For alcohol abuse；\n* Participate in any clinical trail within 30 days;\n* Pregnant or lactating female subjects；\n* Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.；\n* Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.","ALL","18 Years","74 Years",{"count":89,"type":90},405,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","This is a multi-center, randomized, double-blind, placebo\u002Factive-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.",[96],"Postoperative Pain Management","2026-02-11",{"date":99,"type":100},"2026-02-13","ACTUAL",{"date":102,"type":100},"2025-07-28",{"date":104,"type":90},"2026-03-01",{"name":5,"class":6},2]