Abstract
Background
QP001, a novel meloxicam formulation, has been developed to manage moderate to severe postoperative pain. This study aimed to evaluate the efficacy and safety of QP001 injections for moderate to severe pain following abdominal surgery.
Method
This prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial enlisted patients experiencing moderate to severe pain following abdominal surgery. These patients were randomized to receive either QP001 injections (30 mg or 60 mg) or a placebo pre-surgery. The primary efficacy endpoint was the total morphine consumption within 24 h after the first administration.
Results
A total of 108 patients were enrolled, and 106 patients completed the study. The total morphine consumption in the QP001 30 mg group and 60 mg group, versus placebo group, were significantly lower over the following 24 h (5.11[5.46] vs 8.86[7.67], P = 0.011; 3.11[3.08] vs 8.86[7.67], P < 0.001), respectively. The total morphine consumption in the QP001 30 mg and 60 mg groups, versus placebo group, was also significantly decreased over the following 48 h, including the 24–48 h period (P ≤ 0.001). The QP001 30 mg and 60 mg groups, versus placebo, showed a significant decrease in the area under the curve for pain intensity-time as well as a significant decrease in the effective pressing times of the analgesic pump over the 24 h and 48 h periods (P < 0.05). The QP001 groups, versus placebo, show no significant different in Adverse Events or Adverse Drug Reactions (P > 0.05).
Conclusion
Preoperative/preemptive QP001 provides analgesia and reduces opioid consumption in patients with moderate to severe pain following abdominal surgery, while maintaining a favorable safety profile.
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Data availability
The data sets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
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The authors acknowledge the assistance and cooperation of staff from Zhichao Information Technology Co., Ltd.
Funding
The study received funding from the Natural Science Foundation of Hunan Province (2021JJ31022), Nanjing Delova Biotech Co., Ltd. The sponsor had no role in the study design, including in the collection, analysis, or interpretation of the data or in the writing or submission of the manuscript.
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YZ, SW and WO contributed to the study conception and design. YZ, KD, ZB, XH, MX, XL, YG, JL, MY, YZ, WZ, RD and YS performed the research. Data collection and analysis were performed by YZ, SW and BW. The first draft of the manuscript was written by YZ, BW and KD. ZW, YJ, SY and SW were responsible for the visualization of the manuscript. All authors read and approved the final manuscript.
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Zhou, Y., Wang, B., Duan, K. et al. Preemptive QP001, a fast-acting meloxicam formulation, provides analgesia and reduces opioid consumption following abdominal surgery: a randomized controlled trial. Inflammopharmacol 31, 2401–2410 (2023). https://doi.org/10.1007/s10787-023-01322-w
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DOI: https://doi.org/10.1007/s10787-023-01322-w