Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 19 to 75

DA-9701 in functional dyspepsia: see if it helps reduce symptoms

Official title: 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

Run by Dong-A ST Co., Ltd. · NCT07686679 · Data updated 2026-11-12

This study tests whether DA-9701 (and related formulations) can help adults with functional dyspepsia feel better compared with placebo.

Quick facts

PhasePhase 4
Study typeInterventional
Ages19 Years to 75 Years
SexAll
Enrollment300 (estimated)
SponsorDong-A ST Co., Ltd.
Industry-sponsored
Locations1 site (Seoul)
StatusRecruiting
StartedAugust 6, 2026
Main results expectedOctober 2027
Study endsOctober 2027
Registry record updatedAugust 10, 2026
Trial IDNCT07686679 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 19–75 with Rome IV-defined functional dyspepsia and at least three moderate-to-severe GI symptoms.

Probably not a fit

Patients whose symptoms are not driven by functional dyspepsia or who do not respond to the study drug may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial investigates the efficacy and safety of DA-9701 and its formulations versus placebo in adults with functional dyspepsia. Eligible participants are 19 to 75 years old who meet Rome IV criteria and have multiple moderate to severe symptoms. Participants are randomly assigned to receive DA-9701, a DA-9701-R formulation, or their respective placebos, with safety and symptom outcomes monitored. The trial excludes individuals with organic causes of dyspepsia, drug hypersensitivity, or pregnancy. Dong-A ST Co., Ltd. leads the study at Severance Hospital in Seoul, with no named collaborators.

Why it matters

Potential benefit: If successful, participants might experience improved digestive symptoms and a better quality of life related to functional dyspepsia.

How similar studies have gone: Prior studies in related gastroenterology research have shown mixed results; this study adds evidence for DA-9701 in a Phase 4 setting.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Severance Hospital
    Seoul, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.