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

Phase 2RecruitingNCT07543796

Beijing Tide Pharmaceutical Co., Ltd200 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Postoperative Analgesia After Unilateral Hip Arthroplasty

Interventions

TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 dosesDRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 dosesDRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 dosesDRUG

First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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.

At 48 hours after the surgery, the participants and the research doctors respectively evaluated the overall pain relief satisfaction of the test drug used on a 5-point scale, with 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.

Central Contacts

xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd

CONTACT

86-10-6788-0648-5064 zhangxh3@tidepharm.com

Data from ClinicalTrials.gov

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