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Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
Sponsor: Beijing Tide Pharmaceutical Co., Ltd
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-03-18
Completion Date
2026-07-27
Last Updated
2026-04-22
Healthy Volunteers
No
Interventions
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)
Locations (1)
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China