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The Effect of Two Prokinetics in Patients With Functional Dyspepsia

NCT07096921 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-08-05

No results posted yet for this 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.

Conditions

  • Functional Dyspepsia

Interventions

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

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    collaborator INDUSTRY

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Eunpyeong St. Mary's Hospital

    lead OTHER

Principal Investigators

  • JUNG HWAN OH · The Catholic University of Korea Eunpyeong St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2026-03-19
Completion
2026-03-19

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096921 on ClinicalTrials.gov