Efficacy and safety of 4-hydroxy 2-methyl-N-(5-methyl-2-thiazolyl)-2H-1, 2-benzothiazin-3-carboxamide 1,1-dioxide, a fast-acting meloxicam formulation, on moderate-to-severe pain following abdominal surgery: A phase III randomized controlled trial.

ABSTRACT: 4-hydroxy 2-methyl-N-(5-methyl-2-thiazolyl)-2H-1, 2-benzothiazin-3-carboxamide 1,1-dioxide (QP001), a novel long-lasting meloxicam formulation, may provide adequate postoperative pain relief with a good safety profile. This study aimed to evaluate the efficacy and safety of QP001 for moderate-to-severe pain following abdominal surgery. This multicenter, randomized, double-blind, placebo-controlled phase III trial recruited patients undergoing abdominal surgery at 23 centers between October 30, 2022, and July 10, 2023. Patients were randomized to a QP001 or placebo group in a 2:1 ratio. Postoperative pain intensity was evaluated using the Numerical Rating Scale. The primary efficacy outcome was the area under curve (AUC) of pain intensity-time 0-24 h after awakening from anesthesia (AUC

SUBMITTER: Liu X 

PROVIDER: S-EPMC11632392 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature