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A Study to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07686679
Enrollment
300
Registered
2026-07-07
Start date
2026-08-06
Completion date
2027-10-01
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Brief summary

This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia

Interventions

DRUGDA-9701

1 tablet, TID

DRUGDA-9701-R

1 tablet, TID

DRUGDA-9701 Placebo

1 tablet, TID

DRUGDA-9701-R Placebo

1 tablet, TID

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Main Inclusion Criteria: * Men or women aged 19 to 75 years, inclusive * Subjects diagnosed with functional dyspepsia according to the Rome IV criteria * Subjects with at least three symptoms rated as moderate or severe on the Gastrointestinal Symptom Score(GIS) * Subjects who voluntarily signed a consent form Main

Exclusion criteria

* Subjects with a history of organic diseases that could cause dyspepsia * Subjects with hypersensitivity to investigational drugs and similar drugs * Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Changes in GIS(Gastrointestinal Symptom Score) total scoresChange from baseline at 4 weeks

Secondary

MeasureTime frame
Changes in GIS(Gastrointestinal Symptom Score) total scoresChange from baseline at 2 weeks
Changes in GIS(Gastrointestinal Symptom Score) scores by symptomsChange from baseline at 2 weeks and 4 weeks
Changes in NDI-K QoL(Nepean Dyspepsia Index-Korean version Quality of Life) domain scores and total scoresChange from baseline at 4 weeks
Subject's global assessmentat week 4
Investigator's global assessmentat week 4

Countries

South Korea

Contacts

CONTACTSang Kil Lee
SKLEE@yuhs.ac+82) 02-2228-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026