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The Effect of Two Prokinetics in Patients With Functional Dyspepsia
Sponsor: Eunpyeong St. Mary's Hospital
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.
Official title: The Effect of Two Prokinetics in Patients With Functional Dyspepsia : A Prospective, Double Blinded, Multicenter Study
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2025-07-08
Completion Date
2026-03-19
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
Mosapride citrate 5 mg + DA-9701 30 mg
Experimental: Mosapride citrate 5 mg + DA-9701 30 mg, Oral, 3 times/day, 30 min before meals for 4 weeks
Mosapride citrate 5 mg + DA-9701 30 mg placebo
Placebo Comparator: Mosapride citrate 5 mg + DA-9701 placebo, Oral, 3 times/day, 30 min before meals for 4 weeks
Locations (1)
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea