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NOT YET RECRUITING
NCT07491146
PHASE2

Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain

Sponsor: Yingyong Zhou,MD,PhD

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-03-25

Completion Date

2026-12-30

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DRUG

Low dose HSK55718

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

DRUG

Medium Dose HSK55718

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.

DRUG

High dose HSK55718

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

DRUG

Morphine

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

DRUG

Normal saline solution

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)

The Third Xiangya Hospital of Central South University, Changsha, hunan

Changsha, Hunan, China

Sichuan Provincial People's Hospital

Sichuan, China