Postoperative AnalgesiaPhase 2/3NCT07185594
A Phase Ⅱ/Ⅲ Study of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery
A Phase 2/3 study testing HRS-2129 Tablets, Blank Preparation. and Tramadol Hydrochloride SR Tablets in people with Postoperative Analgesia, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
This is a phase II/III, multi-center, randomized, double-blind, comparator-controlled study to evaluate the efficacy and safety of HRS-2129 for postoperative pain management in abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- HRS-2129 Tablets, Blank Preparation. 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
- 360 participants
- Where
- 2 sitesChina
- Study dates
- 24 Oct 2025to Jan 2026
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form before initiating trial-related activities, fully understand the purpose and significance of this trial, and voluntarily comply with the trial procedures;
- Scheduled to undergo abdominal surgery (laparotomy or laparoscopy) under general anesthesia;
- Aged ≥ 18 years (based on the date of signing the informed consent form), regardless of gender;
- Body Mass Index (BMI) between 18.0 kg/m² and 30.0 kg/m² (inclusive);
- American Society of Anesthesiologists (ASA) Physical Status Classification Grade I to II;
- Within 6 hours after surgery (timed from the completion of the last suture), the subject has a Resting Pain Numeric Rating Scale (NRS) score ≥ 4 at any time point;
- Male and female subjects of childbearing potential must agree to use effective contraceptive measures together with their partners from the time of signing the informed consent form until 1 month after the last administration of the investigational product, with no childbearing plans and no intention to donate sperm/eggs; Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the first administration (or within 2 days before surgery) and must not be breastfeeding.
Who cannot join
- Subjects with a history of asthma, chronic urticaria, severe allergic reactions (see Appendix 13.11 for details), allergies to multiple (3 or more) drugs or foods, as well as a personal history or family history of hereditary angioedema before randomization;
- Subjects with a history of new-onset myocardial infarction or unstable angina pectoris within 6 months before randomization, or a history of New York Heart Association (NYHA) Heart Failure Classification Grade II or higher;
- Subjects with a history of arrhythmia requiring treatment before surgery;
- Subjects who developed severe arrhythmia during surgery and were deemed unsuitable for participation in this study by the investigator;
- Subjects with a history of malignant tumor within 5 years before randomization (except for cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma that has been completely resected and is clinically stable);
- Subjects with a previous history of motion sickness, and the investigator judges that they may experience nausea and vomiting after surgery;
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- Subjects with a history of mental system diseases (such as schizophrenia, depression, etc.) and cognitive impairment before randomization;
- Subjects with concurrent pain in various parts of the body, which the investigator believes may confuse the assessment of postoperative pain Subjects with a history of pheochromocytoma before randomization;
- Subjects with concurrent conditions that the investigator believes may affect pain assessment, such as skin or neurological lesions in the affected skin area that may affect sensation;
- Subjects with a previous surgical history at the surgical site;
- QTc interval at screening: > 450 ms for males and > 470 ms for females (QTc calculated using the Fridericia formula); other electrocardiographic abnormalities that are clinically significant as judged by the investigator, which may affect the subject's safety or cause distress to the subject's participation in this clinical trial;
- Subjects with hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) or hypotension (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg) at screening, excluding abnormalities occurring during the period from entry into the operating room to exit from the recovery room;
- Subjects with laboratory test abnormalities at screening;
- Positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus antibody (HCV Ab) at screening (further testing for hepatitis B virus deoxyribonucleic acid (HBV DNA) titer or hepatitis C virus ribonucleic acid (HCV RNA) is required; subjects with results exceeding the detection limit of the assay must be excluded); positive human immunodeficiency virus antibody (HIV Ab); positive serum treponema pallidum antibody (TP Ab) (further testing for treponema pallidum titer is required; subjects with positive results must be excluded);
- Participation in any other clinical study within 3 months before randomization;
- Use of other drugs that affect analgesic efficacy before screening, where the time from the last dose to randomization is less than 5 times the drug's half-life;
- Other circumstances where the investigator judges that the subject is unsuitable for participation in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Min Yan, +86-0571-87783651, yanminnina@hotmail.com
Min Yan
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Jianjun Yang, +86-0371-67967037, jianjunyang1971@163.com
Jianjun Yang
About this study
Official title: A Phase Ⅱ/Ⅲ Study to Evaluate the Efficacy and Safety of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery
This is a phase II/III, multi-center, randomized, double-blind, comparator-controlled study to evaluate the efficacy and safety of HRS-2129 for postoperative pain management in abdominal surgery.
- Conditions
- Postoperative Analgesia
- Being tested
- HRS-2129 Tablets, Blank Preparation., Tramadol Hydrochloride SR Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2129 TabletsDrug
HRS-2129 tablets.
Blank Preparation.Drug
Blank preparation.
Tramadol Hydrochloride SR TabletsDrug
Tramadol Hydrochloride SR tablets.
| Study group | Role | What they receive |
|---|---|---|
| HRS-2129 low-dose group | Experimental | Not described Receives: Drug: HRS-2129 Tablets; Drug: Blank Preparation. |
| HRS-2129 middle-dose group | Experimental | Not described Receives: Drug: HRS-2129 Tablets; Drug: Blank Preparation. |
| HRS-2129 high-dose group | Experimental | Not described Receives: Drug: HRS-2129 Tablets; Drug: Blank Preparation. |
| Blank preparation placebo group | Placebo comparator | Not described Receives: Drug: Blank Preparation. |
| Tramadol Hydrochloride SR Tablets group | Active comparator | Not described Receives: Drug: Tramadol Hydrochloride SR Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product.
Measured: Within 48 hours after the start of administration of the investigational product.
Secondary outcomes (5)
The time-weighted sums of differences in resting pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration (Sum of Pain Intensity Difference, SPID).
Measured: At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
The time-weighted sums of differences in movement-related pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
Measured: At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in resting pain Numeric Rating Scales (NRS) scores from baseline at 24 hours and 48 hours after the first dose.
Measured: At 24 hours and 48 hours after the first dose.
Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in movement-related pain NRS scores from baseline at 24 hours and 48 hours after the first dose.
Measured: At 24 hours and 48 hours after the first dose.
Percentage of subjects who did not use rescue analgesics within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.
Measured: Within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start24 Oct 2025
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
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
- NCT07185594
- Sponsor's protocol ID
- HRS-2129-301
- Status last verified
- Oct 2025
- First submitted
- 15 Sep 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ/Ⅲ Study to Evaluate the Efficacy and Safety of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07185594
- Acronym / sponsor ID
- HRS-2129-301
- Conditions
- Postoperative Analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Sep 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 II/III, multi-center, randomized, double-blind, comparator-controlled study to evaluate the efficacy and safety of HRS-2129 for postoperative pain management in abdominal 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 |
|---|---|---|
| HRS-2129 low-dose group | Experimental | Drug: HRS-2129 Tablets, Drug: Blank Preparation. |
| HRS-2129 middle-dose group | Experimental | Drug: HRS-2129 Tablets, Drug: Blank Preparation. |
| HRS-2129 high-dose group | Experimental | Drug: HRS-2129 Tablets, Drug: Blank Preparation. |
| Blank preparation placebo group | Placebo comparator | Drug: Blank Preparation. |
| Tramadol Hydrochloride SR Tablets group | Active comparator | Drug: Tramadol 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 (7 listed)
- Voluntarily sign the informed consent form before initiating trial-related activities, fully understand the purpose and significance of this trial, and voluntarily comply with the trial procedures;
- Scheduled to undergo abdominal surgery (laparotomy or laparoscopy) under general anesthesia;
- Aged ≥ 18 years (based on the date of signing the informed consent form), regardless of gender;
- Body Mass Index (BMI) between 18.0 kg/m² and 30.0 kg/m² (inclusive);
- American Society of Anesthesiologists (ASA) Physical Status Classification Grade I to II;
Key exclusion criteria (17 listed)
- Subjects with a history of asthma, chronic urticaria, severe allergic reactions (see Appendix 13.11 for details), allergies to multiple (3 or more) drugs or foods, as well as a personal history or family history of hereditary angioedema before randomization;
- Subjects with a history of new-onset myocardial infarction or unstable angina pectoris within 6 months before randomization, or a history of New York Heart Association (NYHA) Heart Failure Classification Grade II or higher;
- Subjects with a history of arrhythmia requiring treatment before surgery;
- Subjects who developed severe arrhythmia during surgery and were deemed unsuitable for participation in this study by the investigator;
- Subjects with a history of malignant tumor within 5 years before randomization (except for cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma that has been completely resected and is clinically stable);
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-2129 TabletsHRS-2129 tablets. | Drug | HRS-2129 high-dose group, HRS-2129 low-dose group, HRS-2129 middle-dose group |
| Blank Preparation.Blank preparation. | Drug | Blank preparation placebo group, HRS-2129 high-dose group, HRS-2129 low-dose group, HRS-2129 middle-dose group |
| Tramadol Hydrochloride SR TabletsTramadol Hydrochloride SR tablets. | Drug | Tramadol Hydrochloride SR Tablets group |
Primary outcome
The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product.
Time frame: Within 48 hours after the start of administration of the investigational product.
5 secondary outcomes
The time-weighted sums of differences in resting pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration (Sum of Pain Intensity Difference, SPID).
Time frame: At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
The time-weighted sums of differences in movement-related pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
Time frame: At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in resting pain Numeric Rating Scales (NRS) scores from baseline at 24 hours and 48 hours after the first dose.
Time frame: At 24 hours and 48 hours after the first dose.
Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in movement-related pain NRS scores from baseline at 24 hours and 48 hours after the first dose.
Time frame: At 24 hours and 48 hours after the first dose.
Percentage of subjects who did not use rescue analgesics within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.
Time frame: Within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.
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 17 Nov 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HRS-2129 Tablets, Blank Preparation. and Tramadol Hydrochloride SR Tablets in people with Postoperative Analgesia, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites 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 7 inclusion and 17 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Lei Tang (+86-0518-82342973, lei.tang.lt31@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product. (time frame: Within 48 hours after the start of administration of the investigational product.). 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 17 Nov 2025.