Actively Recruiting
A Phase II/III Study to Evaluate the Efficacy and Safety of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-11-17
360
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of HRS-2129 for managing pain after abdominal surgery. This phase II/III study is carefully designed to compare HRS-2129 with placebo and Tramadol Hydrochloride sustained-release tablets in patients undergoing abdominal surgery under general anesthesia. The goal is to better understand how well HRS-2129 controls postoperative pain. Participants will be randomly assigned to one of five groups: low, middle, or high doses of HRS-2129 tablets, a placebo group receiving a blank preparation, or a group receiving Tramadol Hydrochloride SR tablets. The study uses a double-blind method where neither participants nor researchers know who receives which treatment. Pain levels will be monitored within 48 hours after starting the study medication. During the study, participants will have their pain intensity assessed at various times up to 48 hours after medication begins. Researchers will measure resting and movement-related pain using numeric rating scales and track the use of additional pain relief medications. Safety and effectiveness will be carefully monitored to evaluate the time-weighted differences in pain experienced by participants. The study is scheduled to end in January 2026.
CONDITIONS
Brief Title
A Phase Ⅱ/Ⅲ Study of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and agree to follow trial procedures
- Scheduled for abdominal surgery (laparotomy or laparoscopy) under general anesthesia
- Aged 18 years or older, any gender
- Body Mass Index between 18.0 and 30.0 kg/m² inclusive
- American Society of Anesthesiologists Physical Status Grade I to II
- Within 6 hours after surgery, resting pain Numeric Rating Scale score of 4 or higher
- Use effective contraception if of childbearing potential and have a negative pregnancy test before first dose; not breastfeeding
You will not qualify if you...
- History of asthma, chronic urticaria, severe allergic reactions, or hereditary angioedema
- New myocardial infarction or unstable angina within 6 months before randomization
- History of arrhythmia requiring treatment before surgery
- Severe arrhythmia during surgery deemed unsuitable by investigator
- History of malignant tumors within 5 years, except stable skin cancers
- History of motion sickness with risk of nausea or vomiting after surgery
- History of mental disorders or cognitive impairment before randomization
- Concurrent pain conditions that may interfere with postoperative pain assessment
- History of pheochromocytoma
- Skin or neurological lesions affecting pain sensation at surgical site
- Previous surgery at the surgical site
- QTc interval above 450 ms for males or 470 ms for females, or other significant ECG abnormalities
- Hypertension above 180/110 mmHg or hypotension below 90/60 mmHg at screening
- Abnormal lab tests at screening
- Positive hepatitis B, hepatitis C, HIV, or syphilis tests
- Participation in other clinical trials within 3 months
- Use of drugs affecting analgesic efficacy within 5 times their half-life before screening
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours after the first dose
Participants receive HRS-2129 tablets, tramadol tablets, or placebo for postsurgical pain management following abdominal surgery.
1 baseline visit and multiple assessments within 48 hours after dosing
Duration - Until study completion
Participants are monitored for safety and efficacy outcomes after treatment ends.
Additional assessments may occur depending on participant response
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
2
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
L
Lei Tang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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