NCT06007066

HSK16149 for Perioperative Analgesia in Orthopedic Surgery

A Multicenter, Randomized, Double-Blind, Placebo-controlled Phase II Study of The Efficacy And Safety of HSK16149 In The Treatment of Patients With Orthopedic Perioperative Analgesia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.

Detailed description

This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h. Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period. Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. After the treatment period, the subjects will be followed up.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	HSK16149 capsule	Subjects will be given 40mg or 60mg of HSK16149 orally.
DRUG	Placebo	Subjects will be given HSK16149 placebo orally.

Timeline

• Start date: 2023-03-08
• Primary completion: 2023-06-12
• Completion: 2023-07-05
• First posted: 2023-08-23
• Last updated: 2023-08-23

Locations

21 sites across 1 country: China