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
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical 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 (AUC0–24). Adverse events and drug reactions were recorded to evaluate safety. A total of 258 patients underwent randomization, and 255 patients received at least one trial drug, including 170 in the QP001 group and 85 in the placebo group. Among these patients, 250 completed the study. The AUC0–24 was significantly lower in the QP001 group than in the placebo group (50.5 vs. 85.19, difference of 34.69 [40.7%], p < 0.0001). This was accompanied by a decrease in morphine use and an increase in patient satisfaction. Moreover, the overall adverse events or adverse drug reaction rates were similar between the QP001 and placebo groups. Among patients undergoing abdominal surgery, postoperative pain was significantly lower in the QP001 group than in the placebo group. QP001 has a great analgesic effect of up to 24 h and satisfactory safety in patients with moderate‐to‐severe abdominal pain.
DOI: 10.1111/cts.70081
Authors: Xiaohua Liu, Yanhua Zhao, Mengchang Yang, Jinghua Ren, Wen Ouyang, Saiying Wang, Yufei Shen, Yuanli Gao, Ling Zhao, Zhong Qin, Jun Cao, Jiangyan Xia, Hongmei Zhou, Haihua Zeng, Jiangang Li, Qiongcan Li, Haitao Jiang, Ruiren Zhou, Kaiming Yuan, Shu’an Jin, Xuanqiang Zhang, Chunhui Wang, Yongquan Chen, Hailong Dong, Jieping Lv, Sen Yu, Yonghui Jiu, Qingsong Wang, Diansan Su, Weifeng Yu
Institutions: Shanghai Jiao Tong University, Renji Hospital, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Second People’s Hospital of Yibin, Third Xiangya Hospital, Nanjing Maternity and Child Health Care Hospital, Xi'an Medical University, Wuxi People's Hospital, Nanjing Medical University, The Affiliated Yongchuan Hospital of Chongqing Medical University, Zhongda Hospital Southeast University, Third Hospital of Changsha, Changsha Central Hospital, First People's Hospital of Nanning, Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Jinan Central Hospital, Yuncheng Central Hospital, First Affiliated Hospital of Wannan Medical College, Xijing Hospital, Air Force Medical University, Shanxi Medical University, First Hospital of Shanxi Medical University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,460
OpenAlex ID: W4405286254