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

June 30, 2026 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sang Kil Lee
  • Phone Number: +82) 02-2228-4000
  • Email: SKLEE@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-9701
administered for 4weeks(DA-9701 + DA-9701-R placebo)
Drug: DA-9701
1 tablet, TID
Drug: DA-9701-R Placebo
1 tablet, TID
Active Comparator: DA-9701-R
administered for 4weeks(DA-9701-R + DA-9701 placebo)
Drug: DA-9701-R
1 tablet, TID
Drug: DA-9701 Placebo
1 tablet, TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in GIS(Gastrointestinal Symptom Score) total scores
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in GIS(Gastrointestinal Symptom Score) total scores
Time Frame: Change from baseline at 2 weeks
Change from baseline at 2 weeks
Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms
Time Frame: Change from baseline at 2 weeks and 4 weeks
Change 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 scores
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Subject's global assessment
Time Frame: at week 4
at week 4
Investigator's global assessment
Time Frame: at week 4
at week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA9701_FD_IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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