Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

نویسندگان

  • 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
چکیده

BACKGROUND/AIMS The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Westerncountries. 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 among3 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. Theprimary 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). Symptomimprovement 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 anddyspepsia-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 efficacyof DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 andpantoprazole in patients with FD.

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عنوان ژورنال:

دوره 22  شماره 

صفحات  -

تاریخ انتشار 2016