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Tests treatment safety and results for Postoperative Analgesia After Unilateral Hip Arthroplasty
Official title Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
ClinicalTrials.gov ID: NCT07543796
What this study is testing
What is TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses?
TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postoperative analgesia after unilateral hip arthroplasty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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 treatment clinical trial within 3 months
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.