Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia

Abstract

Background/AimsTherapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients. MethodsPatients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspeptic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire. ResultsWe randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as ≥ 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of

DA‐9701 improves colonic transit time and symptoms in patients with functional constipation: A prospective study

“…Abdominal bloating occurred in two patients, but this did not significantly affect their appetite, food intake, or quality of life. Previous studies also showed a good safety profile, similar to our results …”

“…One tablet of 30‐mg DA‐9701 (Motilitone, Dong‐A ST, Seoul, Korea) was taken three times per day before a meal for 24 days, and drug compliance was evaluated by checking the remaining tablets on the last day of the study. The dose was selected based on the findings of previous clinical studies . During the study period, patients were prohibited from taking laxatives, rescue medications for constipation, or other GI motility regulators.…”

“…[11][12][13] DA-9701 (Motilitone), a newly developed prokinetic agent for treating patients with functional dyspepsia, is approved for this purpose in South Korea. 14,15 DA-9701 is formulated with the plants Corydalis Tuber and Pharbitis Semen, both of which have been used in Oriental traditional medicine for their anti-ulcer and analgesic effects. [16][17][18] DA-9701, like prucalopride, has shown affinity for the 5-HT 4 receptor.…”

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

“…This finding is consistent with the previous studies. 9,26 Another previous study reported that the complete symptom relief was achieved similarly by PPIs among the FD subgroups; ie, ulcer-like, dysmotility-like, reflux-like, and unspecified dyspepsia. 27 Further clinical investigations are urgently needed to assess the utility of FD subgroups defined by the Rome III criteria in clinical study and practice.…”

Effect of DA-9701 on the Normal Motility and Clonidine-induced Hypomotility of the Gastric Antrum in Rats

“…DA-9701 showed noninferior efficacy to itopride that is known to increase acetylcholine concentrations by inhibiting dopamine D 2 receptors and acetylcholinesterase. 17 Actually, itopride was reported to stimulate gastric motility and accelerate gastric emptying. 18 In several Asian countries such as South Korea and Japan, mosapride citrate (mosapride), a serotonin 5-HT 4 receptor agonist, as well as itopride has been used in patients with FD as a prokinetic drug.…”