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KMID : 1188320180120050516
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Gut and Liver
2018 Volume.12 No. 5 p.516 ~ p.522
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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial
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Yoon Hyuk
Lee Dong-Ho
Lee Yong-Hyun
Jeong Ju-Cheol
Lee Soo-Teik
Choi Myung-Gyu
Jeon Seong-Woo
Shim Ki-Nam
Baik Gwang-Ho
Kim Jae-Gyu
Moon Jeong-Seop
Sung In-Kyung
Lee Sang-Kil
Rhee Poong-Lyul
Jung Hwoon-Yong
Lee Bong-Eun
Kim Hyun-Soo
Kim Sang-Gyun
Lee Kee-Myung
Seong Jae-Kyu
Jang Jin-Seok
Park Jong-Jae
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Abstract
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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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KEYWORD
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Mosapride, Functional dyspepsia, Compliance, Efficacy, Randomized clinical trial
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