Recruiting NCT07543796
Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Postoperative Analgesia After Unilateral Hip Arthroplasty. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Detailed description
This study used Active and placebo as a control to explore the efficacy, safety and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery
Interventions
- Drug 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) - Drug 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) - Drug 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) - Drug 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) - Drug Matching placebo tablets and capsules, same dosing schedule
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
Primary outcome measures
- Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery [Time frame: 0 to 48 hours after surgery]
Secondary outcome measures (7)
- AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively [Time frame: 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively]
- AUC of movement pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively [Time frame: 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively]
- Cumulative morphine-equivalent rescue analgesic dose at 0-4, 0-6, 0-12, 0-24, 0-48 hours [Time frame: 0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery]
- Time to first rescue analgesia [Time frame: Within 48 hours after the surgery, the period from the end of the surgery to the first administration of analgesic medication for relief purposes]
- Number and proportion of participants using rescue analgesia [Time frame: 0-48 hours postoperatively]
- Participant and investigator satisfaction with analgesia with the 5-point scale,the score range from 0 to 4, where 0 indicates poor, 1 indicates average, 2 indicates good, 3 indicates very good, and 4 indicates excellent. [Time frame: 48 hours postoperatively]
- By evaluating security metrics such as AEs, SAEs and TEAEs to evaluate the safety of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty. [Time frame: 5 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Third Affiliated Hospital of Southern Medical University — Guangzhou
Identifiers
NCT: NCT07543796 · TRD205-II-04