title: Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
authors.forename: Hye-Kyung
authors.initials: HK
authors.lastname: Jung
authors.affiliation: Department of Gastroenterology, Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea.
authors.forename: Kwang Jae
authors.initials: KJ
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea.
authors.forename: Myung-Gyu
authors.initials: MG
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hyojin
authors.initials: H
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
authors.forename: Joon Seong
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Poong-Lyul
authors.initials: PL
authors.lastname: Rhee
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.
authors.forename: Nayoung
authors.initials: N
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.
authors.forename: KyungSik
authors.initials: K
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
authors.forename: Suck Chei
authors.initials: SC
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Oh Young
authors.initials: OY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea.
authors.forename: Kyu Chan
authors.initials: KC
authors.lastname: Huh
authors.affiliation: Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Geun Am
authors.initials: GA
authors.lastname: Song
authors.affiliation: Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
authors.forename: Su Jin
authors.initials: SJ
authors.lastname: Hong
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Chong Il
authors.initials: CI
authors.lastname: Sohn
authors.affiliation: Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Hwoon-Yong
authors.initials: HY
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Yong Chan
authors.initials: YC
authors.lastname: Lee
authors.affiliation: Chonnam National University Medical School, Gwangju, Korea.
authors.forename: Jong Sun
authors.initials: JS
authors.lastname: Rew
authors.affiliation: Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
authors.forename: Sam Ryong
authors.initials: SR
authors.lastname: Jee
authors.affiliation: Department of Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, Korea.
authors.forename: Joong Goo
authors.initials: JG
authors.lastname: Kwon
keywords: DA-9701 (Motilitone); Dyspepsia; Proton pump inhibitor
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