TRD205 tablets for postoperative pain after unilateral hip replacement
Official title: 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
Run by Beijing Tide Pharmaceutical Co., Ltd · NCT07543796 · Data updated 2026-11-12
This study will test whether TRD205 tablets relieve pain after unilateral hip replacement better than celecoxib or placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Beijing Tide Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | March 18, 2026 |
| Main results expected | June 27, 2026 |
| Study ends | July 27, 2026 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07543796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–80 years old with BMI 18–32 kg/m2, ASA I–II, scheduled for elective unilateral total hip arthroplasty under general anesthesia and able to take oral medications and provide informed consent.
✕Probably not a fit
Patients with severe liver, kidney, cardiovascular disease, NSAID allergy or NSAID-induced asthma, recent substance abuse, inability to take oral medications, pregnancy or breastfeeding are unlikely to benefit or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase IIb, randomized, double-blind, double-dummy, active- and placebo-controlled trial comparing three oral dose regimens of TRD205 to celecoxib and placebo for postoperative analgesia after unilateral total hip arthroplasty. Participants receive an initial loading dose followed by q12h oral dosing for a total of four doses while pain scores, safety, and pharmacokinetics are monitored. Eligible adults are aged 18–80 with BMI 18–32 kg/m2 and ASA physical status I–II undergoing elective unilateral hip replacement under general anesthesia. The trial is sponsored by Beijing Tide Pharmaceutical and conducted at The Third Affiliated Hospital of Southern Medical University in Guangzhou.
Why it matters
Potential benefit: If successful, TRD205 could provide an effective oral option for controlling pain after hip replacement with a defined dosing schedule and safety profile.
How similar studies have gone: Oral COX-2 inhibitors such as celecoxib have shown effectiveness for postoperative pain, but TRD205 is a novel agent and its safety and efficacy in this setting are not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd
- Email: zhangxh3@tidepharm.com
- Phone: 86-10-6788-0648-5064
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.