J Neurogastroenterol Motil.
2016 Apr;22(2):254-263. 10.5056/jnm15178.
Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study
- Affiliations
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- 1Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
- 2Department of Gastroenterology, Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea. kjleemd@hotmail.com
- 3Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 5Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
- 6Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 7Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.
- 8Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.
- 9Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
- 10Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
- 11Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea.
- 12Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea.
- 13Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 14Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- 15Chonnam National University Medical School, Gwangju, Korea.
- 16Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
- 17Department of Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, Korea.
- KMID: 2203579
- DOI: http://doi.org/10.5056/jnm15178
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.
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