HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials.

ABSTRACT: HSK21542, a peripherally restricted kappa opioid receptor agonist, was evaluated for efficacy and safety in patients with postoperative pain following abdominal surgery. This was assessed in two phase 3, multicentre, randomized, double-blind, controlled trials (HSK21542-301 [ClinicalTrials.gov identifier, NCT04738357] and HSK21542-303 [ClinicalTrials.gov identifier, NCT05390905]) in China. HSK21542-301 was a dual-arm study comparing HSK21542 1.0 μg/kg with placebo, while HSK21542-303 involved three arms comparing HSK21542 1.0 μg/kg with tramadol 50 mg/dose and placebo. All treatments were administered intravenously. The primary endpoint was the time-weighted summed pain intensity differences over 24 h (SPID_0-24 h). Both HSK21542-301 (least squares [LS] mean [± standard error], -

SUBMITTER: Zhong Y 

PROVIDER: S-EPMC12103582 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature