[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634754":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":42,"centralContacts":55,"locations":61,"responsibleParty":78,"collaborators":42,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":42,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":42,"overallStatus":64,"whyStopped":42,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Beijing Tide Pharmaceutical Co., Ltd","INDUSTRY",[8,14,19,24,30],{"label":9,"type":10,"description":11,"interventionNames":12},"200mg treatment group","EXPERIMENTAL","TRD205 Tablets (Low Dose)",[13],"Drug: TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses",{"label":15,"type":10,"description":16,"interventionNames":17},"400mg treatment group","TRD205 Tablets (Middle Dose)",[18],"Drug: TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses",{"label":20,"type":10,"description":21,"interventionNames":22},"600mg treatment group","TRD205 Tablets (High Dose)",[23],"Drug: TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses",{"label":25,"type":26,"description":27,"interventionNames":28},"Active Control (Celecoxib)","ACTIVE_COMPARATOR","Celecoxib Capsules",[29],"Drug: Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses",{"label":31,"type":32,"description":33,"interventionNames":34},"Placebo Control","PLACEBO_COMPARATOR","Placebo for TRD205 and Celecoxib",[35],"Drug: Matching placebo tablets and capsules, same dosing schedule",[37,43,46,49,52],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses","First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)",[9],null,{"type":38,"name":44,"description":40,"armGroupLabels":45,"otherNames":42},"TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses",[15],{"type":38,"name":47,"description":40,"armGroupLabels":48,"otherNames":42},"TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses",[20],{"type":38,"name":50,"description":40,"armGroupLabels":51,"otherNames":42},"Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses",[25],{"type":38,"name":53,"description":40,"armGroupLabels":54,"otherNames":42},"Matching placebo tablets and capsules, same dosing schedule",[31],[56],{"name":57,"role":58,"phone":59,"phoneExt":42,"email":60},"xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd","CONTACT","86-10-6788-0648-5064","zhangxh3@tidepharm.com",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"The Third Affiliated Hospital of Southern Medical University","RECRUITING","Guangzhou","Guangdong","130021","China","CN",{"type":71,"coordinates":72},"Point",[73,74],113.25,23.11667,{"lat":74,"lon":73},[77],{"name":57,"role":58,"phone":59,"phoneExt":42,"email":60},{"type":79,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100634754","phase-2-efficacy-and-safety-of-trd205-tablets-for-postoperative-analgesia-in-unilateral-total-hip-arthroplasty-phase-iib-100634754",false,"NCT07543796","Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)","A Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty","TRD205","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Age 18 to 80 years, inclusive\n* BMI 18-32 kg\u002Fm²\n* ASA physical status I-II\n* Scheduled for elective unilateral total hip arthroplasty under general anesthesia\n* Able to understand study procedures and pain rating scales\n\nExclusion Criteria:\n\n* Hypersensitivity to TRD205, celecoxib, or study-related medications\n* Use of prohibited analgesics, sedatives, CYP3A4 inhibitors\u002Finducers, or analgesic herbs within specified washout periods\n* Inability to take oral medications postoperatively\n* Ipsilateral hip surgery within 1 year; contralateral hip surgery within 1 month\n* Hip revision surgery, developmental dysplasia Crowe type IV, or tumor involving hip\n* Clinically significant hemodynamic instability or cardiac arrhythmia\n* Severe hepatic, renal, cardiovascular, or metabolic disease\n* History of NSAID-induced asthma, active peptic ulcer disease\n* Drug or alcohol abuse within 1 year\n* Pregnancy, breastfeeding, or lack of effective contraception\n* Participation in another interventional clinical trial within 3 months","ALL","18 Years","80 Years",{"count":92,"type":93},200,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","This is a phase IIa, multicenter ,randomized, double-blind, Double-Dummy, Active- and placebo-controlled study designed to evaluate the efficacy, safety and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty",[99],"Postoperative Analgesia After Unilateral Hip Arthroplasty","2026-04-14",{"date":102,"type":103},"2026-04-22","ACTUAL",{"date":105,"type":103},"2026-03-18",{"date":107,"type":93},"2026-07-27",{"name":5,"class":6},1]