NCT05390905

A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment

A Multi-Center, Randomized, Double-Blind, Placebo/Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo/active-controlled study. About 387 subjects undergoing elective abdominal operation under general anesthesia are planned to be enrolled and randomized into the HSK21542 group (129 subjects), tramadol group (129 subjects), and placebo group (129 subjects).

Conditions

• Postoperative Analgesia

Interventions

Type	Name	Description
DRUG	HSK21542 Injection	1μg/kg/dose
DRUG	Tramadol hydrochloride	50mg/dose
DRUG	placebo	placebo

Timeline

• Start date: 2022-06-08
• Primary completion: 2022-12-16
• Completion: 2023-03-28
• First posted: 2022-05-25
• Last updated: 2023-04-04

Locations

1 site across 1 country: China