Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trialopen access
- 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
- Issue Date
- EDITORIAL OFFICE GUT & LIVER
- Mosapride; Functional dyspepsia; Compliance; Efficacy; Randomized clinical trial
- GUT AND LIVER, v.12, no.5, pp.516 - 522
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- GUT AND LIVER
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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 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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- 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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