The Effect of Two Prokinetics in Patients With Functional Dyspepsia

Study Summary

This prospective, double-blinded, randomized, multicenter study will compare the efficacy and safety of two prokinetic regimens in patients with Rome IV-diagnosed functional dyspepsia. Ninety-two patients will be randomized (1:1) to receive either mosapride 5 mg + DA-9701 30 mg or mosapride 5 mg + matching placebo, three times daily before meals for 4 weeks. The primary endpoint is the proportion of overall responders ("much improved" or "very much improved" on a 7-point Likert scale) at Week 4. Secondary endpoints include overall response at Week 2, change in NDI-K symptom scores and PSQI-K sleep quality scores at Week 4, and safety assessments via laboratory tests and adverse-event monitoring.