Postoperative Analgesia After Unilateral Hip ArthroplastyPhase 2NCT07121101
To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty
A Phase 2 study testing TRD205 tablets in people with Postoperative Analgesia After Unilateral Hip Arthroplasty, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Analgesia After Unilateral Hip Arthroplasty
- What is being tested?
- TRD205 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2025to 27 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 18 to 80 years of age, male or female;
- 18 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.
Who cannot join
- 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;
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- 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;
- History of psychotropic drug and narcotic drug abuse, drug abuse and alcoholism within 1 year before randomization, i.e., those who drink more than 2 units of alcohol on average per day (1 unit = 360 mL of beer or 45 mL of 40% liquor or 150 mL of wine);
- Abnormal blood routine at screening: neutrophil count < 1.5 × 10 9 /L; platelet count < 100 × 10 9 /L; hemoglobin (Hb) < 80 g/L;
- Abnormal liver function in the screening period: ALT and/or AST ≥ 1.5 times the upper limit of normal, or total bilirubin ≥ 1.5 times the upper limit of normal;
- Abnormal renal function in the screening period: serum creatinine (Cr) ≥ 1.5 times the upper limit of normal and/or dialysis participants;
- Abnormal coagulation function during screening period: prothrombin time (PT) prolonged by more than 3 seconds and/or activated partial thromboplastin time (APTT) prolonged by more than 10 seconds;
- Patients with positive syphilis antibody (Syphilis TP) and human immunodeficiency virus antibody (HIV-Ab) tests during the screening period who are not suitable for participating in the trial at the investigator's discretion;
- Pregnant or lactating women;
- Those who are unwilling or unable to take effective contraceptive measures during the study or 30 times after the study;
- Participated in other drug or device clinical study within 3 months before randomization (signed ICF and received the investigational drug/device or placebo treatment, for medication or treatment, start timing);
- Other conditions that the investigator considers inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
Rongkai Zhang, 020-62784066, nysygcp@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty
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
Read the detailed description
This study used a placebo as a control to explore the safety, efficacy and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery
- Being tested
- TRD205 tablets, placebo
- Keywords
- TRD205、postoperative analgesia after unilateral hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRD205 tabletsDrug
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
TRD205 tabletsDrug
Administered orally every 12 hours for a total of four times；Take TRD205 4 tablets and Placebo 2 tablets for the first time ，TRD205 2 tablets and Placebo 1 tablets each for the other three times.
TRD205 tabletsDrug
Administered orally every 12 hours for a total of four times；Take TRD205 6 tablets and Placebo 0 tablets for the first time ，TRD205 3 tablets and Placebo 0 tablets each for the other three times.
placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Within 48 hours after the first administration
Secondary outcomes (5)
Peak Plasma Concentration（Cmax）
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Measured: From 1 hour before the first administration to 48 hours after the last administration.
Minimum concentration （Cmin)
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Measured: From 1 hour before the first administration to 48 hours after the last administration
Time to peak（Tmax）
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Measured: From 1 hour before the first administration to 48 hours after the last administration
elimination half life（T1/2）
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Measured: From 1 hour before the first administration to 48 hours after the last administration
Area under the plasma concentration versus time curve （AUC）
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Measured: From 1 hour before the first administration to 48 hours after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start26 Sep 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion27 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Analgesia After Unilateral Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Third Affiliated Hospital of Southern Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121101
- Sponsor's protocol ID
- TRD205-II-02
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07121101
- Acronym / sponsor ID
- TRD205-II-02
- Keywords
- TRD205、postoperative analgesia after unilateral hip arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- The Third Affiliated Hospital of Southern Medical University
- Study start
- 26 Sep 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 27 Dec 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study used a placebo as a control to explore the safety, efficacy and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200mg treatment group | Experimental | Drug: TRD205 tabletsAdministered 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. |
| 400mg treatment group | Experimental | Drug: TRD205 tabletsAdministered orally every 12 hours for a total of four times；Take800mg tablets for the first time and 400mg each for the other three times. |
| 600mg treatment group | Experimental | Drug: TRD205 tabletsAdministered 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. |
| Placebo | Placebo comparator | Drug: placeboAdministered 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- 18 to 80 years of age, male or female;
- 18 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;
Key exclusion criteria (25 listed)
- 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:
- Concomitant with other pain conditions that may confound the postoperative pain evaluation as judged by the investigator;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRD205 tabletsAdministered 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 | Drug | 200mg treatment group |
| TRD205 tabletsAdministered orally every 12 hours for a total of four times；Take TRD205 4 tablets and Placebo 2 tablets for the first time ，TRD205 2 tablets and Placebo 1 tablets each for the other three times. | Drug | 400mg treatment group |
| TRD205 tabletsAdministered orally every 12 hours for a total of four times；Take TRD205 6 tablets and Placebo 0 tablets for the first time ，TRD205 3 tablets and Placebo 0 tablets each for the other three times. | Drug | 600mg treatment group |
| placeboAdministered 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. | Drug | Placebo |
Primary outcome
Treatment-Related Adverse Events
Time frame: 5 days
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.
The total dose of morphine was administered to the patient 0 to 48 hours after the operation
Time frame: Within 48 hours after the first administration
To evaluate the efficacy of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
5 secondary outcomes
Peak Plasma Concentration（Cmax）
Time frame: From 1 hour before the first administration to 48 hours after the last administration.
Minimum concentration （Cmin)
Time frame: From 1 hour before the first administration to 48 hours after the last administration
Time to peak（Tmax）
Time frame: From 1 hour before the first administration to 48 hours after the last administration
elimination half life（T1/2）
Time frame: From 1 hour before the first administration to 48 hours after the last administration
Area under the plasma concentration versus time curve （AUC）
Time frame: From 1 hour before the first administration to 48 hours after the last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Analgesia After Unilateral Hip Arthroplasty
RecruitingPhase 2
Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
Postoperative Analgesia After Unilateral Hip Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRD205 tablets in people with Postoperative Analgesia After Unilateral Hip Arthroplasty, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yingying wang (+ 86-10-6788-0648-5064, wangyy6@tidepharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Related Adverse Events (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.