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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
200mg treatment group
TRD205 Tablets (Low Dose)
干预措施: TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses (Drug)
400mg treatment group
TRD205 Tablets (Middle Dose)
干预措施: TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses (Drug)
600mg treatment group
TRD205 Tablets (High Dose)
干预措施: TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses (Drug)
Active Control (Celecoxib)
Celecoxib Capsules
干预措施: Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses (Drug)
Placebo Control
Placebo for TRD205 and Celecoxib
干预措施: Matching placebo tablets and capsules, same dosing schedule (Drug)
结局指标
主要结局
Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery
时间窗: 0 to 48 hours after surgery
次要结局
- AUC of movement pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively(0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively)
- AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively(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(0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery)
- Time to first rescue analgesia(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(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.(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.(5 days)