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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial

Yoon, H | Lee, DH | Lee, YH | Jeong, JC | Lee, ST | Choi, MG | Jeon, SW | Shim, KN | Baik, GH | Kim, JG | Moon, JS | Sung, IK | Lee, SK | Rhee, PL | Jung, HY | Lee, BE | Kim, HS | Kim, SG | Lee, KM  | Seong, JK | Jang, JS | Park, JJ
Gut and liver, 12(5). : 516-522, 2018
Journal Title
Gut and liver
BACKGROUND/AIMS: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD).
METHODS: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events.
RESULTS: A total of 138 patients were enrolled (female, 73.9%: mean age, 44.0+/-15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%+/-4.52% vs 96.85%+/-6.05%, p=0.870). Changes in GIS scores were -9.69+/-6.44 and -10.01+/-5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, -1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups.
CONCLUSIONS: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.

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