Efficacy and safety of rebamipide/nizatidine in patients with erosive gastritis: A randomized, multicenter, phase 4 study.

Background: For the treatment of gastritis, rebamipide, a mucoprotective agent, and nizatidine, a gastric acid suppressant, are commonly employed individually.

Aim: To compare the efficacy of Mucotra SR (rebamipide 150 mg) and Axid (nizatidine 150 mg) combination therapy with the sole administration of Axid in managing erosive gastritis.

Methods: A total of 260 patients diagnosed with endoscopically confirmed erosive gastritis were enrolled in this open-label, multicenter, randomized, phase 4 clinical trial, allocating them into two groups: Rebamipide/nizatidine combination twice daily nizatidine twice daily for 2 weeks. The full-analysis set analysis encompassed 239 patients (rebamipide/nizatidine, = 121; nizatidine, = 118), while the per-protocol analysis included 218 patients ( = 110 108). Post-treatment assessments comprised primary (erosion improvement rate) and secondary (erosion and edema cure rates, erythema improvement rates, hemorrhage, and gastrointestinal symptoms) endpoints. Furthermore, drug-related adverse effects were evaluated.

Results: Primary efficacy assessment showed a statistically significant improvement rate in mucosal erosions in the combination group compared to the control group in the full-analysis set (rebamipide/nizatidine 62.0%, nizatidine 49.2%, = 0.046), with a similar trend noted in the per-protocol analysis (62.7% 50.0%, = 0.058). Both groups were effective in curing erosion and edema and improvement of bleeding, erythema, and gastrointestinal symptoms, whereas no inter-group differences were noted. When confined to the participants with gastritis symptoms, improvement of erosion was more optimal in the combination group (63.0% 49.5%, = 0.046). No adverse events related to the drugs were observed.

Conclusion: Rebamipide/nizatidine combination is effective in treatment of erosive gastritis.