NCT07096921

The Effect of Two Prokinetics in Patients With Functional Dyspepsia

The Effect of Two Prokinetics in Patients With Functional Dyspepsia : A Prospective, Double Blinded, Multicenter Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Eunpyeong St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A four-visit schedule: screening (Visit 1), randomization (Visit 2, same day), telephone follow-up at Week 2, and on-site assessment at Week 4. Screening includes informed consent, demographics, medical history, concomitant medications, labs, Rome IV questionnaire. Randomization uses opaque sealed envelopes generated by an independent statistician. Investigational products are dispensed in a double-dummy design to maintain blinding. Treatment compliance, vital signs, AEs collected at each contact. Efficacy via Likert scale, NDI-K, PSQI-K; safety via labs and AE reporting.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2025-07-08
• Primary completion: 2026-03-19
• Completion: 2026-03-19
• First posted: 2025-07-31
• Last updated: 2025-08-05

Locations

1 site across 1 country: South Korea