Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain
To Evaluate the Efficacy and Safety of HSK55718 for Injection in Patients With Abdominal Postoperative Pain: a Multicenter, Randomized, Double-blind, Placebo/Positive Control Phase II Clinical Trial.
Yingyong Zhou,MD,PhD
200 participants
May 23, 2026
INTERVENTIONAL
Conditions
Summary
A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then 30mg HSK55718 injection or normal saline was given intermittently every 6 hours.
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, normal saline solution was given intravenously as the first dose, and then normal saline solution was given intermittently every 6 hours
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07491146