💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- 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
The Third Affiliated Hospital of Southern Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky