Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb) (TRD205)

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Analgesia After Unilateral Hip Arthroplasty
• Intervention / Treatment: Drug: TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses; Drug: TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses; Drug: TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses; Drug: Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses; Drug: Matching placebo tablets and capsules, same dosing schedule

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd; Phone Number: 86-10-6788-0648-5064; Email: zhangxh3@tidepharm.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 130021
      • Recruiting
      • The Third Affiliated Hospital of Southern Medical University
      • Contact: xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd; Phone Number: 86-10-6788-0648-5064; Email: zhangxh3@tidepharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200mg treatment group; TRD205 Tablets (Low Dose)	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)
Experimental: 400mg treatment group; TRD205 Tablets (Middle Dose)	Drug: 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)
Experimental: 600mg treatment group; TRD205 Tablets (High Dose)	Drug: 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)
Active Comparator: Active Control (Celecoxib); Celecoxib Capsules	Drug: 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)
Placebo Comparator: Placebo Control; Placebo for TRD205 and Celecoxib	Drug: Matching placebo tablets and capsules, same dosing schedule; First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
AUC of movement 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
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
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
Number and proportion of participants using rescue analgesia		0-48 hours postoperatively
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
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

Collaborators and Investigators

• Sponsor: Beijing Tide Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): July 27, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Dosage Forms; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Pyrazoles; Celecoxib; Capsules
• Other Study ID Numbers: TRD205-II-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No