Postoperative Pain in OrthopaedicsPhase 1/2NCT06780267
Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics
A Phase 1/2 study testing HRS-2129 and Tramadol Hydrochloride SR Tablets in people with Postoperative Pain in Orthopaedics, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain in Orthopaedics
- What is being tested?
- HRS-2129 and Tramadol Hydrochloride SR Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to 3 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Subjects requiring elective orthopedic surgery
- Conform to the ASA Physical Status Classification
Who cannot join
- Subjects with a history of severe allergies
- Subjects with nervous system disease
- Subjects with a history of mental illness
- Subjects with abnormal liver and renal function
- Subjects with poorly controlled hypertensive or hypotensive
- QTc：>450ms（male），>470ms（female）
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- Subjects who screened positive for substance abuse
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
About this study
Official title: Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.
- Conditions
- Postoperative Pain in Orthopaedics
- Being tested
- HRS-2129, HRS-2129 placebo, Tramadol Hydrochloride SR Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2129Drug
HRS-2129
HRS-2129 placeboDrug
HRS-2129 placebo
Tramadol Hydrochloride SR TabletsDrug
Tramadol Hydrochloride SR Tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: low\middle\high-dose | Experimental | HRS-2129； HRS-2129 placebo Receives: Drug: HRS-2129; Drug: HRS-2129 placebo |
| Treatment group:placebo | Experimental | HRS-2129 placebo Receives: Drug: HRS-2129 placebo |
| Treatment group: positive control | Active comparator | Tramadol Hydrochloride SR Tablets Receives: Drug: Tramadol Hydrochloride SR Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety：Incidence and severity of AE/SAE
Measured: from ICF signing date to day 12 since last dose(14 days)
Secondary outcomes (9)
the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition
Measured: 48hours
The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication
Measured: 48hours
Participant ' satisfaction score for analgesia treatment
Measured: 48hours
Investigator satisfaction score for analgesia treatment
Measured: 48hours
Time of first use of remedial analgesic medication
Measured: 48hours
Cumulative use of remedial analgesics
Measured: 48hours
Cmax
Measured: 5 days
Tmax
Measured: 5 days
AUC0-12h
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 posted17 Jan 2025
- Study start11 Mar 2025
- Primary completion19 Mar 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain in OrthopaedicsStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780267
- Sponsor's protocol ID
- HRS-2129-103
- Status last verified
- May 2026
- First submitted
- 13 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
- ClinicalTrials.gov ID
- NCT06780267
- Acronym / sponsor ID
- HRS-2129-103
- Conditions
- Postoperative Pain in Orthopaedics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 17 Jan 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.
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group: low\middle\high-dose | Experimental | Drug: HRS-2129, Drug: HRS-2129 placeboHRS-2129； HRS-2129 placebo |
| Treatment group:placebo | Experimental | Drug: HRS-2129 placeboHRS-2129 placebo |
| Treatment group: positive control | Active comparator | Drug: Tramadol Hydrochloride SR TabletsTramadol Hydrochloride SR Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to provide a written informed consent
- Subjects requiring elective orthopedic surgery
- Conform to the ASA Physical Status Classification
Key exclusion criteria (9 listed)
- Subjects with a history of severe allergies
- Subjects with nervous system disease
- Subjects with a history of mental illness
- Subjects with abnormal liver and renal function
- Subjects with poorly controlled hypertensive or hypotensive
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 |
|---|---|---|
| HRS-2129HRS-2129 | Drug | Treatment group: low\middle\high-dose |
| HRS-2129 placeboHRS-2129 placebo | Drug | Treatment group: low\middle\high-dose, Treatment group:placebo |
| Tramadol Hydrochloride SR TabletsTramadol Hydrochloride SR Tablets | Drug | Treatment group: positive control |
Primary outcome
Safety：Incidence and severity of AE/SAE
Time frame: from ICF signing date to day 12 since last dose(14 days)
9 secondary outcomes
the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition
Time frame: 48hours
The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication
Time frame: 48hours
Participant ' satisfaction score for analgesia treatment
Time frame: 48hours
Investigator satisfaction score for analgesia treatment
Time frame: 48hours
Time of first use of remedial analgesic medication
Time frame: 48hours
Cumulative use of remedial analgesics
Time frame: 48hours
Cmax
Time frame: 5 days
Tmax
Time frame: 5 days
AUC0-12h
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-2129 and Tramadol Hydrochloride SR Tablets in people with Postoperative Pain in Orthopaedics, run by Shandong Suncadia Medicine 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 2 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety：Incidence and severity of AE/SAE (time frame: from ICF signing date to day 12 since last dose(14 days)). 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 2 Jun 2026.