Efficacy and safety of DWJ1252 compared with gasmotin in the treatment of functional dyspepsia: A multicenter, randomized, double-blind, active-controlled study

Jin Hwa Park, Kang Nyeong Lee, Oh Young Lee, Myung Gyu Choi, Hyunsoo Chung, Suck Chei Choi, Nayoung Kim, Hyojin Park, In Kyung Sung, Chong Il Sohn, Sam Ryong Jee, Jae Young Jang, Poong Lyul Rhee, Moo In Park, Joong Goo Kwon, Kyung Sik Park, Kwang Jae Lee, Joon Seong Lee

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1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)87-96
Number of pages10
JournalJournal of Neurogastroenterology and Motility
Volume27
Issue number1
DOIs
Publication statusPublished - 2021 Jan

Bibliographical note

Publisher Copyright:
© 2021 The Korean Society of Neurogastroenterology and Motility.

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Gastroenterology

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