Rebamipide and Misoprostol: Multicenter RCT-STORM 151 misoprostol at the primary endpoint was considered demon- strated when the 95% two-sided confidence intervals of the difference between the rebamipide and misoprostol groups was not less than the pre-specified limit of equivalence of − 0.07 and not more than the pre-specified limit of equivalence of 0.07. A categorical model underlying the confidence interval with the center and treatment as fixed factors was used. Laboratory tests, age, sex, H. pylori infection status, and body weight measurements from pretreatment to post- treatment were analyzed both within and between the treatment groups using Student’s unpaired t test or the Wilcoxon rank-sum test. A shift table with chi-square analysis of the change in normal range from baseline was last values over the course of the study. All statistical tests were two-sided, with a 5% level of significance. In addition, 95% two-sided confidence intervals were used. The SAS program (Ver. 8.1) was used for statistical analyses. Results Demographic characteristics of patients A total of 456 patients were scheduled to undergo endo- scopic screening for enrollment in this trial. Forty-six patients were excluded during the screening period, and 410 patients were enrolled and evaluated (Fig. 2). The numbers of enrolled patients from China, Korea, and Thailand were 174, 153, and 83, respectively. The treatment groups were well-balanced with respect to treatment with NSAIDs, sex, age, and frequency of H. pylori infection (Table 1). The most commonly used NSAIDs were diclofenac (36.8%), aceclofenac (34.9%), and naproxen (7.8%) (Table 2). Evaluation of the incidence of gastrointestinal ulcers and adverse events included 207 patients in the rebamipide group and 203 in the misoprostol group. For this analysis, 31 patients were excluded from the rebamipide group and 47 from the misoprostol group because of adverse events, patient’s request, or other reasons (Fig. 2). Prevalence of peptic ulcer The prevalences of gastric ulcer during the 12-week study period were 7/176 (3.9%) in the rebamipide group and 3/156 (1.9%) in the misoprostol group. The prevalences of duodenal ulcer were 1/176 (0.5%) in the rebamipide group and 4/156 (2.5%) in the misoprostol group. Peptic ulcer was Fig. 2. Enrollment and randomization of the studied population Symptoms; Two patients had intractable pain, and 2 were vomiting in the rebamipide group. One had stomach pain, 4 had abdominal distension, 2 had lower abdominal pain, and 5 had intractable diarrhea in the misoprostol group. Vol. 40, No. 2, 2007