Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT07543796
Recruiting Phase 2

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

NCT07543796 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tide Pharmaceutical Co., Ltd
Phase
Phase 2
Started
2026-03-18
Last updated
2026-04-22

Condition(s) studied

Postoperative Analgesia After Unilateral Hip Arthroplasty

Investigational drug(s) / intervention(s)

TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses →TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses →TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses →Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses →Matching placebo tablets and capsules, same dosing schedule

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)

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
The Third Affiliated Hospital of Southern Medical University Guangzhou Guangdong Recruiting

More Beijing Tide Pharmaceutical Co., Ltd trials in China

To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery Starting soon
TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD)) Active, not recruiting
A Phase I/II Clinical Study in Patients with Advanced Solid Tumor. Recruiting
Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects Recruiting
An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors Recruiting

Other trials for the same condition

To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07543796 on ClinicalTrials.gov ↗ ← All trials in China