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RecruitingPhase 2NCT07543796

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

Sponsor

Beijing Tide Pharmaceutical Co., Ltd

Enrollment

200 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

Postoperative Analgesia After Unilateral Hip Arthroplasty

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria11

  • 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

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Interventions

DRUGTRD205 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)

DRUGTRD205 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)

DRUGTRD205 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)

DRUGCelecoxib, 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)

DRUGMatching 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

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NCT07543796