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

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.

Figure 1

Inclusion and exclusion flow chart for enrollment of study participants. The causes of per protocol (PP) set failure are as follows: for DA-9701 group, dropout (n = 4), exclusion criteria (n = 2), deviation of standard for drug compliance (n = 7), and deviation of randomization (n = 1); for pantoprazole group, dropout (n = 5), deviation of standard for drug compliance (n = 12), deviation of randomization (n = 1), and taking prohibited drugs (n = 4); for DA-9701 + pantoprazole group, dropout (n = 4), exclusion criteria (n = 1), deviation of standard for drug compliance (n = 10), and taking prohibited drugs (n = 3). F/U, follow-up.

Figure 2

Symptomatic relief according to the Helicobacter pylori status. In the H. pylori positive group, the symptom improvement rate was significantly higher in the pantoprazole and DA-9701 + pantroprazole group than that in DA-9701 group. However, this difference was not detected in the H. pylori-negative group. The Chi-square test was performed among the 3 groups and Bonferroni-Holm’s step-down was used for comparison within each group.