Dose finding study of mosapride in functional dyspepsia: a placebo‐controlled, randomized study

Abstract

Background: Prokinetic agents have shown variable efficacy in the treatment of functional dyspepsia. Mosapride is a new prokinetic 5‐hydroxytryptamine‐4 agonistic agent. Aim: To evaluate the efficacy of three dosage regimens of mosapride compared with placebo in the treatment of functional dyspepsia. Methods: Patients were randomly allocated to treatment with placebo or mosapride (5 mg b.d., 10 mg b.d. or 7.5 mg t.d.s.) in a double‐blind, prospective, multicentre, multinational study. The change in symptom severity score from an untreated baseline week to the sixth week of treatment was used to compare treatment efficacy. Results: There were 141, 140, 143 and 142 patients valid for evaluation in the intention‐to‐treat population in the placebo, mosapride 5 mg b.d., mosapride 10 mg b.d. and mosapride 7.5 mg t.d.s. groups, respectively. The mean changes in the overall dyspeptic symptom score were – 0.90, – 0.94, – 0.88 and – 0.89, respectively, and the proportions of patients feeling better at the end of the treatment period were 60%, 59%, 59% and 61%, respectively. No statistically significant difference was seen. Conclusions: Treatment of functional dyspepsia with mosapride was not superior to placebo. The result raises the question of whether treatment with prokinetic agents is appropriate for functional dyspepsia.

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

“…13 However, itopride and mosapride have shown variable efficacy in the treatment of FD, particularly in placebo-controlled randomized studies. 19,20 To date, there is no report regarding a placebo controlled trial of DA-9701 in patients with FD. Therefore, the efficacy of DA-9701 in FD needs to be confirmed.…”

“…However, currently available gastroprokinetic agents have some demerits such as adverse effects or conflicting efficacy data. [6][7][8] DA-9701 is a novel prokinetic agent formulated with the extracts of Pharbitis Semen and Corydalis Tuber. These plants have been used in oriental traditional medicine.…”

Prokinetics in the Management of Functional Gastrointestinal Disorders

“…to placebo during a 6-week treatment period. 39 In the intention-to-treat analysis of 566 patients there was no difference in dyspeptic symptoms between placebo and any of the 3 mosapride treatment groups. All other studies in FD have been small with no placebo group, and often limited by the lack of a validated screening instrument.…”

Prokinetic effects of LD02GIFRO on functional gastrointestinal disorder in rats

“…However, two gastroprokinetic agents, domperidone and tegaserod, are associated with serious side effects (14,15), and the efficacy data on two others, mosapride and itopride, are conflicting (16,17). Therefore, there is a requirement for safer and more effective gastroprokinetic agents to be developed.…”