To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty

NCT07121101 | Not Yet Recruiting Phase 2

• 1 other identifier: TRD205-II-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IIa, multicenter ,randomized, double-blind, placebo-controlled study designed to evaluate the safety, efficacy and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty

Conditions

Postoperative Analgesia After Unilateral Hip Arthroplasty

Keywords

TRD205、postoperative analgesia after unilateral hip arthroplasty

Outcome Measures

Primary Outcomes (2)

• Treatment-Related Adverse Events

  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

• The total dose of morphine was administered to the patient 0 to 48 hours after the operation

  To evaluate the efficacy of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty

  Within 48 hours after the first administration

Secondary Outcomes (5)

• Peak Plasma Concentration（Cmax）

  From 1 hour before the first administration to 48 hours after the last administration.

• Minimum concentration （Cmin)

  From 1 hour before the first administration to 48 hours after the last administration

• Time to peak（Tmax）

  From 1 hour before the first administration to 48 hours after the last administration

• elimination half life（T1/2）

  From 1 hour before the first administration to 48 hours after the last administration

• Area under the plasma concentration versus time curve （AUC）

  From 1 hour before the first administration to 48 hours after the last administration

Study Arms (4)

200mg treatment group

EXPERIMENTAL

Administered orally every 12 hours for a total of four times；Take 400mg tablets for the first time and 200mg each for the other three times.

Drug: TRD205 tablets

400mg treatment group

EXPERIMENTAL

Administered orally every 12 hours for a total of four times；Take800mg tablets for the first time and 400mg each for the other three times.

Drug: TRD205 tablets

600mg treatment group

EXPERIMENTAL

Administered orally every 12 hours for a total of four times；Take 1200mg tablets for the first time and 600mg each for the other three times.

Drug: TRD205 tablets

Placebo

PLACEBO COMPARATOR

Administered orally every 12 hours for a total of four times；Take 6 tablets for the first time and 3 tablets each for the other three times

Drug: placebo

Interventions

TRD205 tablets DRUG

Administered orally every 12 hours for a total of four times；Take TRD205 2 tablets and Placebo 4 tablets for the first time ，TRD205 1 tablets and Placebo 2 tablets each for the other three times

200mg treatment group

placebo DRUG

Administered orally every 12 hours for a total of four times；Take Placebo 6 tablets for the first time ，Placebo 3 tablets each for the other three times.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent form, and voluntarily comply with the trial procedures;
• to 80 years of age, male or female;
• kg/m 2 ≤ BMI ≤ 32 kg/m 2 , Incl. Cutoff ;
• American Society of Anesthesiologists (ASA) physical status I to II (Appendix 6);
• Unilateral total hip arthroplasty under general anesthesia is planned, and PCIA analgesia is expected to be required within 48 hours after surgery;
• Able to understand the study procedures and the use of various scales involved in this study, and able to communicate effectively with the investigators.

You may not qualify if:

• Known allergies or contraindications to the investigational drug and other drugs that may be used during the trial, and those who are not suitable for participating in the trial judged by the investigator;
• Use the following drugs within 5 half-lives before randomization (subject to the actual drug instructions, if the half-life is unknown, wash out according to 48h), including but not limited to: analgesic drugs (except specified in the protocol), anticonvulsants, sedative-hypnotic drugs (except used according to the protocol), anxiolytics, antidepressants, CYP3A4 enzyme inhibitors or inducers, etc., use of Chinese herbal medicine with clear analgesic effect assessed by the investigator within 7 days before randomization; sign the ICF to successfully use intra-articular injection of cocktail therapy (specific drugs include but not limited to local anesthetics such as ropivacaine, lidocaine, bupivacaine; analgesics such as morphine; steroid drugs such as dexamethasone and methylprednisolone); refer to the list of prohibited drugs for specific types;
• Patients who cannot take oral drugs after surgery as judged by the investigator;
• Combining the following:
• Patients who received ipsilateral hip surgery within 1 year before randomization;
• Patients who received hip surgery within 3 months before randomization;
• Patients scheduled for unilateral hip revision surgery;
• Patients who receive total hip arthroplasty due to developmental dysplasia of the hip Type III-IV (see Appendix 9 for Crowe classification), femoral or acetabular tumor, femoral neck fracture and/or femoral neck fracture (excluding old femoral neck fracture, which is treated with internal fixation removal + total hip arthroplasty), and are not suitable for this study at the investigator's discretion;
• Patients planning to undergo surgery at other sites at the same time during the study;
• Concomitant with other pain conditions that may confound the postoperative pain evaluation as judged by the investigator;
• Sitting systolic blood pressure ≤ 90 mmHg at screening, or sitting diastolic blood pressure ≤ 50 mmHg at screening, and clinically significant abnormalities as judged by the investigator;
• Heart rate \< 50 beats/min or heart rate \> 100 beats/min during the screening period, and clinically significant abnormalities as judged by the investigator; or QTcF \> 450 ms in males and QTcF \> 470 ms in females \[calculated by Fridericia's formula: QTcF = QT/(RR0.33)\]; or participants with a history of severe arrhythmia such as type II atrioventricular block or above, or a history of cardiac insufficiency;
• Patients complicated with severe liver, kidney, cardiovascular and cerebrovascular diseases, metabolic system diseases, and should not participate in this trial at the discretion of the investigator;
• Participants with malignant tumor who are not suitable for participating in the study as judged by the investigator;
• Patients complicated with mental system diseases (such as schizophrenia, depression, etc.), dementia, migraine, history of epilepsy, and unsuitable for participating in the trial judged by the investigator;

Sponsors & Collaborators

• Beijing Tide Pharmaceutical Co., Ltd: lead
• The Third Affiliated Hospital of Southern Medical University: collaborator

Study Sites (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Central Study Contacts

yingying wang

CONTACT

+ 86-10-6788-0648-5064; wangyy6@tidepharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 13, 2025
• Study Start: September 26, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 27, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)