Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Препарат 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)
• Препарат 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)
• Препарат 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)
• Препарат 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)
• Препарат Matching placebo tablets and capsules, same dosing schedule
  First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

Первичные конечные точки

• Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery [Срок оценки: 0 to 48 hours after surgery]

Вторичные конечные точки (7)

• AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery]
• Time to first rescue analgesia [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 5 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Affiliated Hospital of Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07543796 · TRD205-II-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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