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 <scp>III</scp> randomized controll

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<sub>0-24</sub>). 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 AUC<sub>0-24</sub> 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.

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Publication Details

Journal
Clinical and Translational Science
Published
2024-12-01
DOI
https://doi.org/10.1111/cts.70081
Citations
3
Primary Topic
Anesthesia and Pain Management
Type
article
Field-Weighted Citation Impact
1.72

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article

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 controll

Zhong Qin, Yufei Shen, Xuanqiang Zhang, Diansan Su et al.
3 citations
Clinical and Translational Science
Anesthesia and Pain Management
1.72
article

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 controll

Zhong Qin, Yufei Shen, Xuanqiang Zhang, Diansan Su, Jiangang Li, Qiongcan Li, Hailong Dong, Hongmei Zhou, Wen Ouyang, Haitao Jiang, Jieping Lv, C.-c. Wang, Ruiren Zhou, Yuanli Gao, Jinghua Ren, Xiaohua Liu, Shuan Jin, Jiangyan Xia, Mengchang Yang, Jun Cao, Sen Yu, Yongquan Chen, Yanhua Zhao, Kaiming Yuan, Weifeng Yu, Q. Wang, Saiying Wang, Haihua Zeng, Ling Zhao, Yonghui Jiu
article en
3 citations

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<sub>0-24</sub>). 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 AUC<sub>0-24</sub> 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.

Clinical and Translational ScienceVol. 17(12)
Yuncheng University (CN), Central South University (CN), Shanxi Medical University (CN), Shanghai Jiao Tong University (CN), Wenzhou Medical University (CN), Renji Hospital (CN), Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University (CN), Nanjing Maternity and Child Health Care Hospital (CN), Changsha Central Hospital (CN), Qujing Normal University (CN), Zhongda Hospital Southeast University (CN), Jinan Central Hospital (CN), Xi'an Medical University (CN), Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (CN), First Hospital of Shanxi Medical University (CN), The Affiliated Yongchuan Hospital of Chongqing Medical University (CN), Yueyang Second People's Hospital (CN), First Hospital of Jiaxing (CN), First People's Hospital of Nanning (CN), Anhui Mental Health Center (CN), Second People’s Hospital of Yibin (CN), Third Xiangya Hospital (CN), Wuxi People's Hospital (CN), Xijing Hospital (CN), Third Hospital of Changsha (CN), First Affiliated Hospital of Wannan Medical College (CN), Yuncheng Central Hospital, Nanjing Medical University (CN), Chongqing Medical University (CN)
National Natural Science Foundation of China
Good health and well-being
Openalex Percentile: Top 14%
Anesthesia and Pain Management
1.72
DOIOpen Access PDFOpenAlex
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