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

Authors
Yoon, HyukLee, Dong HoLee, Yong-HyunJeong, Ju-CheolLee, Soo TeikChoi, Myung-GyuJeon, Seong WooShim, Ki-NamBaik, Gwang HoKim, Jae GyuMoon, Jeong SeopSung, In-KyungLee, Sang KilRhee, Poong-LyulJung, Hwoon-YongLee, Bong EunKim, Hyun SooKim, Sang GyunLee, Kee MyungSeong, Jae KyuJang, Jin SeokPark, Jong-Jae
Issue Date
Sep-2018
Publisher
EDITORIAL OFFICE GUT & LIVER
Keywords
Mosapride; Functional dyspepsia; Compliance; Efficacy; Randomized clinical trial
Citation
GUT AND LIVER, v.12, no.5, pp.516 - 522
Indexed
SCIE
SCOPUS
KCI
Journal Title
GUT AND LIVER
Volume
12
Number
5
Start Page
516
End Page
522
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/3196
DOI
10.5009/gnl17416
ISSN
1976-2283
Abstract
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 end-point 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 UI05MSP015CT (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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Park, Jong Jae
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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