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J Neurogastroenterol Motil. 2016 Apr 30;22(2):254-63. doi: 10.5056/jnm15178.

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

Author information

1
Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
2
Department of Gastroenterology, Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea.
3
Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea.
4
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
5
Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
6
Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
7
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.
8
Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.
9
Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
10
Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
11
Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea.
12
Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea.
13
Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
14
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
15
Chonnam National University Medical School, Gwangju, Korea.
16
Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
17
Department of Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, Korea.

Abstract

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.

KEYWORDS:

DA-9701 (Motilitone); Dyspepsia; Proton pump inhibitor

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