Clinical Trial

The Effect of Two Prokinetics in Patients With Functional Dyspepsia

Active, Not Recruiting
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Record status
This record was last updated August 5, 2025 (before its estimated March 19, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-29.
Trial Details
NCT Number NCT07096921
Lead Sponsor Eunpyeong St. Mary's Hospital
Collaborators: Dong-A ST Co., Ltd., Daewoong Pharmaceutical Co. LTD.
Conditions Functional Dyspepsia
Enrollment 92 participants
Start Date 2025-07-08
Primary Completion 2026-03-19 (estimated)
Study Completion 2026-03-19 (estimated)
Updated on ClinicalTrials.gov 2025-08-05