Postoperative Analgesia After Unilateral Hip Arthroplasty
Investigational drug(s) / intervention(s)
TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 dosesTRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 dosesTRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 dosesCelecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses →Matching placebo tablets and capsules, same dosing schedule
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)
TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses: First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses: First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses: First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
Matching placebo tablets and capsules, same dosing schedule: First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Able to provide written informed consent
* Age 18 to 80 years, inclusive
* BMI 18-32 kg/m²
* ASA physical status I-II
* Scheduled for elective unilateral total hip arthroplasty under general anesthesia
* Able to understand study procedures and pain rating scales
Exclusion Criteria:
* Hypersensitivity to TRD205, celecoxib, or study-related medications
* Use of prohibited analgesics, sedatives, CYP3A4 inhibitors/inducers, or analgesic herbs within specified washout periods
* Inability to take oral medications postoperatively
* Ipsilateral hip surgery within 1 year; contralateral hip surgery within 1 month
* Hip revision surgery, developmental dysplasia Crowe type IV, or tumor involving hip
* Clinically significant hemodynamic instability or cardiac arrhythmia
* Severe hepatic, renal, cardiovascular, or metabolic disease
* History of NSAID-induced asthma, active peptic ulcer disease
* Drug or alcohol abuse within 1 year
* Pregnancy, breastfeeding, or lack of effective contraception
* Participation in another interventional clinical trial within 3 months
Primary outcome measure(s)
Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery — 0 to 48 hours after surgery
Trial sites (1)
Facility
City
Region
Status
The Third Affiliated Hospital of Southern Medical University
Guangzhou
Guangdong
Recruiting
More Beijing Tide Pharmaceutical Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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