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

Authors
 Hyuk Yoon  ;  Dong Ho Lee  ;  Yong-Hyun Lee  ;  Ju-Cheol Jeong  ;  Soo Teik Lee  ;  Myung-Gyu Choi  ;  Seong Woo Jeon  ;  Ki-Nam Shim  ;  Gwang Ho Baik  ;  Jae Gyu Kim  ;  Jeong Seop Moon  ;  In-Kyung Sung  ;  Sang Kil Lee  ;  Poong-Lyul Rhee  ;  Hwoon-Yong Jung  ;  Bong Eun Lee  ;  Hyun Soo Kim  ;  Sang Gyun Kim  ;  Kee Myung Lee  ;  Jae Kyu Seong  ;  Jin Seok Jang  ;  Jong-Jae Park 
Citation
 GUT AND LIVER, Vol.12(5) : 516-522, 2018 
Journal Title
 GUT AND LIVER 
ISSN
 1976-2283 
Issue Date
2018
Keywords
Compliance ; Efficacy ; Functional dyspepsia ; Mosapride ; Randomized clinical trial
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 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.
Files in This Item:
T201803412.pdf Download
DOI
10.5009/gnl17416
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Sang Kil(이상길) ORCID logo https://orcid.org/0000-0002-0721-0364
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/163745
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