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

Efficacy and Safety of QP001 for Postoperative Pain Relief

Study Overview

QP001 is a new formulation of meloxicam designed to relieve moderate-to-severe pain after abdominal surgery. This study aimed to assess its effectiveness and safety.

Trial Details

This phase III trial involved 258 patients across 23 centers from October 30, 2022, to July 10, 2023. Patients were randomly assigned to receive either QP001 or a placebo in a 2:1 ratio. Pain levels were measured using a Numerical Rating Scale.

Key Findings

  • The pain intensity over the first 24 hours after surgery was significantly lower in the QP001 group compared to the placebo group (50.5 vs. 85.19).
  • Patients in the QP001 group used less morphine and reported higher satisfaction with their pain management.
  • Adverse events were similar between both groups, indicating a good safety profile for QP001.

Conclusion

QP001 effectively reduces postoperative pain for up to 24 hours and is safe for patients after abdominal surgery.

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