Postoperative Analgesia After Unilateral Hip ArthroplastyPhase 2TRD205NCT07543796
Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)
A Phase 2 study testing TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses, TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses and TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses 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, 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 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, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses, TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses and TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 27 Jul 2026
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd contact
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 130021
xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd, 86-10-6788-0648-5064, zhangxh3@tidepharm.com
About this study
Official 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
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
Read the 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
- Being tested
- TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses, TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses, TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses, Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses, Matching placebo tablets and capsules, same dosing schedule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 dosesDrug
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
Matching placebo tablets and capsules, same dosing scheduleDrug
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
| Study group | Role | What they receive |
|---|---|---|
| 200mg treatment group | Experimental | TRD205 Tablets (Low Dose) Receives: Drug: TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses |
| 400mg treatment group | Experimental | TRD205 Tablets (Middle Dose) Receives: Drug: TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses |
| 600mg treatment group | Experimental | TRD205 Tablets (High Dose) Receives: Drug: TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses |
| Active Control (Celecoxib) | Active comparator | Celecoxib Capsules Receives: Drug: Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses |
| Placebo Control | Placebo comparator | Placebo for TRD205 and Celecoxib Receives: Drug: Matching placebo tablets and capsules, same dosing schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery
Measured: 0 to 48 hours after surgery
Secondary outcomes (7)
AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively
Measured: 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
Measured: 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
Measured: 0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery
Time to first rescue analgesia
Measured: 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
Measured: 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.
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start18 Mar 2026
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Jul 2026 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543796
- Sponsor's protocol ID
- TRD205-II-04
- Acronym
- TRD205
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07543796
- Acronym / sponsor ID
- TRD205 / TRD205-II-04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Jul 2026 (estimated)
- First posted
- 22 Apr 2026 (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, 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 200mg treatment group | Experimental | Drug: TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 dosesTRD205 Tablets (Low Dose) |
| 400mg treatment group | Experimental | Drug: TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 dosesTRD205 Tablets (Middle Dose) |
| 600mg treatment group | Experimental | Drug: TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 dosesTRD205 Tablets (High Dose) |
| Active Control (Celecoxib) | Active comparator | Drug: Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 dosesCelecoxib Capsules |
| Placebo Control | Placebo comparator | Drug: Matching placebo tablets and capsules, same dosing schedulePlacebo for TRD205 and Celecoxib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 dosesFirst dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) | Drug | 200mg treatment group |
| TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 dosesFirst dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) | Drug | 400mg treatment group |
| TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 dosesFirst dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) | Drug | 600mg treatment group |
| Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 dosesFirst dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) | Drug | Active Control (Celecoxib) |
| Matching placebo tablets and capsules, same dosing scheduleFirst dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) | Drug | Placebo Control |
Primary outcome
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
7 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.
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.
Time frame: 5 days
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 22 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Analgesia After Unilateral Hip Arthroplasty
Not yet recruitingPhase 2
To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty
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.
xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd contact
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, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses, TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses and TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses 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 11 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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 xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd (86-10-6788-0648-5064, zhangxh3@tidepharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 22 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.