clinical trial · NCT07543796
Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
Beijing Tide Pharmaceutical Co., Ltd·phase2·recruiting·n = 200
Postoperative Analgesia After Unilateral Hip ArthroplastyTRD205 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 dosesMatching placebo tablets and capsules, same dosing schedule
brief 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
started
Mar 18, 2026
primary completion
Jun 27, 2026
completion
Jul 27, 2026
last updated
Apr 22, 2026
detailed description
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
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol