J Neurogastroenterol Motil.  2021 Jan;27(1):87-96. 10.5056/jnm20061.

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

Affiliations
  • 1Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
  • 2Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea
  • 3Department of Internal Medicine, Seoul National University, Seoul, Korea
  • 4Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea
  • 5Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea
  • 6Department of Internal Medicine, Yonsei University Gangnam Hospital, Seoul, Korea
  • 7Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea
  • 8Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 9Department of Internal Medicine, Inje University College of Medicine, Busan, Korea
  • 10Department of Internal Medicine, Kyunghee University College of Medicine, Seoul, Korea
  • 11Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 12Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea
  • 13Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea
  • 14Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea
  • 15Department of Internal Medicine, Ajou University College of Medicine, Suwon, Gyeonggi-do, Korea
  • 16Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea

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.

Keyword

Dyspepsia; Gastrointestinal disease; Mosapride
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