MULTI-CENTER, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND, NON-INFERIORITY, PHASE 3 CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF UI05MSP015CT IN FUNCTIONAL DYSPEPSIA (MARS STUDY)

OBJECTIVE: The drug compliance is very important in the treatment of functional dyspepsia. The aim of this study was to evaluate the efficacy and safety of once‐daily mosapride (UI05MSP015CT) in patients with functional dyspepsia. METHODS: Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. during 4 weeks. Primary endpoint was change of gastrointestinal symptom score (GSS) that was evaluated at enrollment and at 4 weeks. Secondary endpoints were change of quality of life evaluated using Nepean Dyspepsia Index‐Korean version (NDI‐K), general symptom improvement, and rate of adverse events. RESULTS: A total of 138 patients with functional dyspepsia (study group: 70, control group: 68) were enrolled between November 2004 and August 2015 in 19 university tertiary care centers in South Korea (intention‐to‐treat (ITT) analysis set; female 71.3%, mean age 44.0 ± 15.4). Fifty nine patients in the study group and 58 patients in the control group were included for per‐protocol (PP) analysis. There were no significant differences in the baseline characteristics including drug compliance between the study and control groups (ITT/PP 95.5%/96.9% vs. 96.3%/97.1%, p = 0.375/0.087). The change of GSS for ITT/PP analysis was ‐9.69 ± 6.44/‐9.80 ± 6.00 and ‐10.01 ± 5.92/‐10.03 ± 5.53 in the study and control groups, respectively. Mean difference of GSS change between the two groups was 0.33 (95% CI ‐1.75, 2.41) and 0.24 (95% CI ‐ 1.88, 2.35) for ITT/PP analysis, demonstrating non‐inferiority of UI05MSP015CT (p = 0.755/0.824). The rate of general symptom improvement (loss or remarkable improvement of symptom) for ITT/PP analysis was not different between the study and control groups (ITT/PP 37.1%/39.0% vs. 55.9%/56.9%, p = 0.0274/0.351). There was no difference in the change of NDI‐K score between the study and control groups (ITT/PP 13.8/14.3 vs. 16.7/16.9, p = 0.204/0.263). There was no difference in the rates of adverse events between the study and control groups (13.24% vs. 4.29%. p = 0.062). CONCLUSIONS: Once‐daily mosapride (UI05MSP015CT) is not inferior to the conventional mosapride in the efficacy and as safe as the conventional mosapride in patients with functional dyspepsia.