Efficacy and safety of polaprezinc in the treatment of gastric ulcer: A multicenter, randomized, double-blind, double-dummy, positive-controlled clinical trial.

OBJECTIVE

To investigate the clinical efficacy and safety of polaprezinc compared with rebamipide in the treatment of gastric ulcers (GU).

METHODS

GU patients (n = 224) from 10 clinical centers were prospectively enrolled and randomly divided into a control (n = 113) or test (n = 111) group. The control group was treated with rebamipide tablets, while the test group was treated with polaprezinc. The primary endpoint was the effective treatment rate, which was confirmed by gastroscopy after 8 weeks of treatment. The secondary efficacy endpoint was the improvement rate of gastrointestinal symptoms after 4 and 8 weeks of treatment.

RESULTS

The basic characteristics of the two groups were well balanced. For the primary efficacy endpoint, the effective rates confirmed by gastroscopy, after treatment for the test and control groups were 81.48% and 74.31% (P = 0.1557), respectively. After 4 and 8 weeks of treatments, both treatment groups had comparable improvements rates in gastrointestinal symptoms (test vs. control: 44.44% vs. 39.45% [P = 0.4559] and 81.48% vs. 77.06% [P = 0.4223]). Further, the two groups had similar adverse events and reactions to the study drugs.

CONCLUSION

These findings suggest that the efficacy and safety of polaprezinc were similar to those of rebamipide in the treatment of GU.