Your browser doesn't support javascript.
loading
Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study
Journal of Neurogastroenterology and Motility ; : 254-263, 2016.
Article in English | WPRIM | ID: wpr-84972
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.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: Quality of Life / Asian People / Dyspepsia / Proton Pump Inhibitors / Gastric Emptying / Hypersensitivity Type of study: Controlled clinical trial Limits: Humans Language: English Journal: Journal of Neurogastroenterology and Motility Year: 2016 Type: Article

Similar

MEDLINE

...
LILACS

LIS

Full text: Available Index: WPRIM (Western Pacific) Main subject: Quality of Life / Asian People / Dyspepsia / Proton Pump Inhibitors / Gastric Emptying / Hypersensitivity Type of study: Controlled clinical trial Limits: Humans Language: English Journal: Journal of Neurogastroenterology and Motility Year: 2016 Type: Article