Actively Recruiting
Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
Led by Beijing Tide Pharmaceutical Co., Ltd · Updated on 2026-04-22
200
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Age 18 to 80 years, inclusive
- BMI 18-32 kg/m8
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 130021
Actively Recruiting
Research Team
X
xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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