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Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study

Authors
 Park, Jin Hwa  ;  Lee, Kang Nyeong  ;  Lee, Oh Young  ;  Choi, Myung-Gyu  ;  Chung, Hyunsoo  ;  Choi, Suck-Chei  ;  Kim, Nayoung  ;  Park, Hyojin  ;  Sung, In-Kyung  ;  Sohn, Chong Il  ;  Jee, Sam Ryong  ;  Jang, Jae Young  ;  Rhee, Poong-Lyul  ;  Park, Moo In  ;  Kwon, Joong Goo  ;  Park, Kyung Sik  ;  Lee, Kwang Jae  ;  Lee, Joon Seong 
Citation
 JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY, Vol.27(1) : 87-96, 2021-01 
Journal Title
 JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY 
ISSN
 2093-0879 
Issue Date
2021-01
Keywords
Dyspepsia ; Gastrointestinal disease ; Mosapride
Abstract
Background/Aims Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD. Methods In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed. Results The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean +/- SD: -10.04 +/- 4.45 and -10.86 +/- 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events. Conclusion In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.
DOI
10.5056/jnm20061
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Hyo Jin(박효진) ORCID logo https://orcid.org/0000-0003-4814-8330
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/181876
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