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

NCT07543796 | Recruiting Phase 2

• 1 other identifier: TRD205-II-04
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Analgesia After Unilateral Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (5)

200mg treatment group

EXPERIMENTAL

TRD205 Tablets (Low Dose)

Drug: TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses

400mg treatment group

EXPERIMENTAL

TRD205 Tablets (Middle Dose)

Drug: TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses

600mg treatment group

EXPERIMENTAL

TRD205 Tablets (High Dose)

Drug: TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses

Active Control (Celecoxib)

ACTIVE COMPARATOR

Celecoxib Capsules

Drug: Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses

Placebo Control

PLACEBO COMPARATOR

Placebo for TRD205 and Celecoxib

Drug: Matching placebo tablets and capsules, same dosing schedule

Interventions

TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses DRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

200mg treatment group

TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses DRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

400mg treatment group

TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses DRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

600mg treatment group

Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses DRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

Active Control (Celecoxib)

Matching placebo tablets and capsules, same dosing schedule DRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

Placebo Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tide Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 130021, China

RECRUITING

MeSH Terms

Interventions

Celecoxib; Capsules

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd

CONTACT

86-10-6788-0648-5064; zhangxh3@tidepharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): July 27, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)