Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.
- Author:
Hye Kyung JUNG
1
;
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
Author Information
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords: DA-9701 (Motilitone); Dyspepsia; Proton pump inhibitor
- MeSH: Asian Continental Ancestry Group; Dyspepsia*; Gastric Emptying; Humans; Hypersensitivity; Proton Pump Inhibitors; Quality of Life
- From:Journal of Neurogastroenterology and Motility 2016;22(2):254-263
- CountryRepublic of Korea
- Language:English
- 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.
