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

Title
Efficacy of da-9701 (motilitone) in functional dyspepsia compared to pantoprazole: A multicenter, randomized, double-blind, non-inferiority study
Authors
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.
Ewha Authors
정혜경
SCOPUS Author ID
정혜경scopus
Issue Date
2016
Journal Title
Journal of Neurogastroenterology and Motility
ISSN
2093-0879JCR Link
Citation
vol. 22, no. 2, pp. 254 - 263
Keywords
DA-9701 (Motilitone)DyspepsiaProton pump inhibitor
Publisher
Journal of Neurogastroenterology and Motility
Indexed
SCIE; SCOPUS; KCI WOS scopus
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. © 2016 The Korean Society of Neurogastroenterology and Motility.
DOI
10.5056/jnm15178
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의과대학 > 의학과 > Journal papers
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