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

April 14, 2026 updated by: Beijing Tide Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd
  • Phone Number: 86-10-6788-0648-5064
  • Email: zhangxh3@tidepharm.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 130021
        • Recruiting
        • The Third Affiliated Hospital of Southern Medical University
        • Contact:
          • xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd
          • Phone Number: 86-10-6788-0648-5064
          • Email: zhangxh3@tidepharm.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 200mg treatment group
TRD205 Tablets (Low Dose)
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)
Experimental: 400mg treatment group
TRD205 Tablets (Middle Dose)
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)
Experimental: 600mg treatment group
TRD205 Tablets (High Dose)
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)
Active Comparator: Active Control (Celecoxib)
Celecoxib Capsules
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)
Placebo Comparator: Placebo Control
Placebo for TRD205 and Celecoxib
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
0 to 48 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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.
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
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tide Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRD205-II-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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