Efficacy of da-9701 (motilitone) in functional dyspepsia compared to pantoprazole: A multicenter, randomized, double-blind, non-inferiority study

Hye Kyung Jung, Kwang Jae Lee, Myung Gyu Choi, Hyojin Park, Joon Seong Lee, Poong Lyul Rhee, Nayoung Kim, Kyung Sik Park, Suck Chei Choi, Oh Young Lee, Kyu Chan Huh, Geun Am Song, Su Jin Hong, Chong Il Sohn, Hwoon Yong Jung, Yong Chan Lee, Jong Sun Rew, Sam Ryong Jee, Joong Goo Kwon

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Abstract

Background/Aims The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. Methods In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. Results The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA- 9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups. Conclusions DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacy of DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 and pantoprazole in patients with FD.

Original languageEnglish
Pages (from-to)254-263
Number of pages10
JournalJournal of Neurogastroenterology and Motility
Volume22
Issue number2
DOIs
Publication statusPublished - 2016 Apr 1

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Gastroenterology

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    Jung, H. K., Lee, K. J., Choi, M. G., Park, H., Lee, J. S., Rhee, P. L., Kim, N., Park, K. S., Choi, S. C., Lee, O. Y., Huh, K. C., Song, G. A., Hong, S. J., Sohn, C. I., Jung, H. Y., Lee, Y. C., Rew, J. S., Jee, S. R., & Kwon, J. G. (2016). Efficacy of da-9701 (motilitone) in functional dyspepsia compared to pantoprazole: A multicenter, randomized, double-blind, non-inferiority study. Journal of Neurogastroenterology and Motility, 22(2), 254-263. https://doi.org/10.5056/jnm15178