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NCT Number: NCT07543796

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

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

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Key information

Conditions

Postoperative Analgesia After Unilateral Hip Arthroplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 130021, China

Location status: Recruiting

Location contact

xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd

CONTACT

[email protected]

86-10-6788-0648-5064

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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 doses

Drug

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 doses

Drug

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

Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses

Drug

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

Matching placebo tablets and capsules, same dosing schedule

Drug

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. Number and proportion of participants using rescue analgesia

    Time frame: 0-48 hours postoperatively

  6. 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

    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.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd

CONTACT

[email protected]

86-10-6788-0648-5064

Sponsors and collaborators

Lead sponsor

Beijing Tide Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Acronym: TRD205

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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