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 modera...
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Wiley
2024-12-01
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| Series: | Clinical and Translational Science |
| Online Access: | https://doi.org/10.1111/cts.70081 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Xiaohua Liu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b5a33c44982841e09d9a6973dd2f52bf |
| institution | Kabale University |
| issn | 1752-8054 1752-8062 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
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| series | Clinical and Translational Science |
| spelling | doaj-art-b5a33c44982841e09d9a6973dd2f52bf2024-12-24T15:26:30ZengWileyClinical and Translational Science1752-80541752-80622024-12-011712n/an/a10.1111/cts.70081Efficacy 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 trialXiaohua Liu0Yanhua Zhao1Mengchang Yang2Jinghua Ren3Wen Ouyang4Saiying Wang5Yufei Shen6Yuanli Gao7Ling Zhao8Zhong Qin9Jun Cao10Jiangyan Xia11Hongmei Zhou12Haihua Zeng13Jiangang Li14Qiongcan Li15Haitao Jiang16Ruiren Zhou17Kaiming Yuan18Shu’an Jin19Xuanqiang Zhang20Chunhui Wang21Yongquan Chen22Hailong Dong23Jieping Lv24Sen Yu25Yonghui Jiu26Qingsong Wang27Diansan Su28Weifeng Yu29Department of Anesthesiology, Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Anesthesiology, Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Anesthesiology, Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital Chengdu ChinaDepartment of Anesthesiology The Second People's Hospital of Yibin Yibin ChinaDepartment of Anesthesiology The Third Xiangya Hospital of Central South University Changsha ChinaDepartment of Anesthesiology The Third Xiangya Hospital of Central South University Changsha ChinaDepartment of Gynaecology Nanjing Women and Children's Healthcare Hospital Nanjing ChinaDepartment of Anesthesiology Maanshan People's Hospital Maanshan ChinaDepartment of Anesthesiology The First Affiliated Hospital of Xi'an Medical University Xi'an ChinaDepartment of Anesthesiology Nanjing Medical University Affiliated Wuxi People's Hospital Wuxi ChinaDepartment of Anesthesiology The First Affiliated Hospital of Chongqing Medical University Chongqing ChinaDepartment of Anesthesiology Zhongda Hospital Southeast University Nanjing ChinaDepartment of Anesthesiology The Second Hospital of Jiaxing Jiaxing ChinaDepartment of Anesthesiology The Third Hospital of Changsha Changsha ChinaDepartment of Anesthesiology Qujing No.1 Hospital Nanjing ChinaDepartment of Anesthesiology Changsha Central Hospital Changsha ChinaDepartment of Anesthesiology Yueyang People's Hospital Yueyang ChinaDepartment of Anesthesiology The First People's Hospital of Nanning Nanning ChinaDepartment of Anesthesiology The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU Wenzhou ChinaDepartment of Anesthesiology Jinan Central Hospital Jinan ChinaDepartment of Anesthesiology Shanxi Yuncheng Central Hospital Yuncheng ChinaDepartment of Anesthesiology Anhui Public Health Clinical Center Hefei ChinaDepartment of Anesthesiology The First Affiliated Hospital of Wannan Medical College Wuhu ChinaDepartment of Anesthesiology Xijing Hospital of Air Force Military Medical University Xi'an ChinaDepartment of Anesthesiology First Hospital of Shanxi Medical University Taiyuan ChinaNanjing Delova Biotech Co., Ltd Nanjing ChinaNanjing Delova Biotech Co., Ltd Nanjing ChinaNanjing Delova Biotech Co., Ltd Nanjing ChinaDepartment of Anesthesiology, Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Anesthesiology, Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaAbstract 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.https://doi.org/10.1111/cts.70081 |
| spellingShingle | 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 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 Clinical and Translational Science |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://doi.org/10.1111/cts.70081 |
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