[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634754":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":46,"studyPopulation":11,"armGroups":47,"interventions":76,"overallOfficials":11,"centralContacts":94,"locations":100,"responsibleParty":117,"collaborators":11,"id":119,"slug":11,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":11,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":11,"overallStatus":103,"whyStopped":11,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Beijing Tide Pharmaceutical Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery",null,"0 to 48 hours after surgery",[14,17,19,22,25,28,32],{"measure":15,"description":11,"timeFrame":16},"AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively","0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively",{"measure":18,"description":11,"timeFrame":16},"AUC of movement pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively",{"measure":20,"description":11,"timeFrame":21},"Cumulative morphine-equivalent rescue analgesic dose at 0-4, 0-6, 0-12, 0-24, 0-48 hours","0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery",{"measure":23,"description":11,"timeFrame":24},"Time to first rescue analgesia","Within 48 hours after the surgery, the period from the end of the surgery to the first administration of analgesic medication for relief purposes",{"measure":26,"description":11,"timeFrame":27},"Number and proportion of participants using rescue analgesia","0-48 hours postoperatively",{"measure":29,"description":30,"timeFrame":31},"Participant and investigator satisfaction with analgesia with the 5-point scale,the score range from 0 to 4, where 0 indicates poor, 1 indicates average, 2 indicates good, 3 indicates very good, and 4 indicates excellent.","At 48 hours after the surgery, the participants and the research doctors respectively evaluated the overall pain relief satisfaction of the test drug used on a 5-point scale, with the score range from 0 to 4, where 0 indicates poor, 1 indicates average, 2 indicates good, 3 indicates very good, and 4 indicates excellent.","48 hours postoperatively",{"measure":33,"description":11,"timeFrame":34},"By evaluating security metrics such as AEs, SAEs and TEAEs to evaluate the safety of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty.","5 days",{"allocation":36,"interventionModel":37,"interventionModelDescription":11,"primaryPurpose":38,"observationalModel":11,"timePerspective":11,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":11,"whoMasked":41},"QUADRUPLE",[42,43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study used Active and placebo as a control to explore the efficacy, safety and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery",[48,54,59,64,70],{"label":49,"type":50,"description":51,"interventionNames":52},"200mg treatment group","EXPERIMENTAL","TRD205 Tablets (Low Dose)",[53],"Drug: TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses",{"label":55,"type":50,"description":56,"interventionNames":57},"400mg treatment group","TRD205 Tablets (Middle Dose)",[58],"Drug: TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses",{"label":60,"type":50,"description":61,"interventionNames":62},"600mg treatment group","TRD205 Tablets (High Dose)",[63],"Drug: TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses",{"label":65,"type":66,"description":67,"interventionNames":68},"Active Control (Celecoxib)","ACTIVE_COMPARATOR","Celecoxib Capsules",[69],"Drug: Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses",{"label":71,"type":72,"description":73,"interventionNames":74},"Placebo Control","PLACEBO_COMPARATOR","Placebo for TRD205 and Celecoxib",[75],"Drug: Matching placebo tablets and capsules, same dosing schedule",[77,82,85,88,91],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":11},"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)",[49],{"type":78,"name":83,"description":80,"armGroupLabels":84,"otherNames":11},"TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses",[55],{"type":78,"name":86,"description":80,"armGroupLabels":87,"otherNames":11},"TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses",[60],{"type":78,"name":89,"description":80,"armGroupLabels":90,"otherNames":11},"Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses",[65],{"type":78,"name":92,"description":80,"armGroupLabels":93,"otherNames":11},"Matching placebo tablets and capsules, same dosing schedule",[71],[95],{"name":96,"role":97,"phone":98,"phoneExt":11,"email":99},"xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd","CONTACT","86-10-6788-0648-5064","zhangxh3@tidepharm.com",[101],{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"The Third Affiliated Hospital of Southern Medical University","RECRUITING","Guangzhou","Guangdong","130021","China","CN",{"type":110,"coordinates":111},"Point",[112,113],113.25,23.11667,{"lat":113,"lon":112},[116],{"name":96,"role":97,"phone":98,"phoneExt":11,"email":99},{"type":118,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":130,"type":131},200,"ESTIMATED","INTERVENTIONAL",[134],"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",[137],"Postoperative Analgesia After Unilateral Hip Arthroplasty","2026-04-14",{"date":140,"type":141},"2026-04-22","ACTUAL",{"date":143,"type":141},"2026-03-18",{"date":145,"type":131},"2026-07-27",{"name":5,"class":6},1]