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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Dong-A ST Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | August 6, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07686679 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
- Study coordinator: Sang Kil Lee
- Email: SKLEE@yuhs.ac
- Phone: +82) 02-2228-4000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Low-FODMAP Diet vs Standard Dietary Advice for Functional Dyspepsia
This study tests whether a low-FODMAP diet helps adults with functional dyspepsia compared with standard dietary advice.
-
Pain Reprocessing Therapy for Functional Dyspepsia
A small pilot test to see if a psychological therapy that uses exposure techniques can lessen digestive symptoms and help daily functioning in people with functional dyspepsia.
-
Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa
This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.
-
Prevalence and possible role of non-H. pylori Helicobacter species in gastric conditions and cancers
Researchers will test stomach tissue from people with functional dyspeasia, various gastritis conditions, gastric cancer, and bariatric patients to see if non-H. pylori Helicobacter species are present.
-
Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity
This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.
-
Prevalence of Functional Dyspepsia in a Rural Community in Bangladesh
This study tests how common functional dyspepsia is in a rural Bangladeshi community among adults who live there.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.