Actively Recruiting
Phase IIIII Study of HRS-2129 for Managing Pain After Abdominal Surgery
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-11-17
360
Participants Needed
2
Research Sites
4 weeks
Total Duration
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 IIIII 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
Research Team
L
Lei Tang
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