Functional DyspepsiaPhase 4NCT07686679
A Study to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia
A Phase 4 study testing DA-9701 and DA-9701-R in people with Functional Dyspepsia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- DA-9701 and DA-9701-R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Aug 2026to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
Sang Kil Lee, +82) 02-2228-4000, SKLEE@yuhs.ac
About this study
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
This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia
- Conditions
- Functional Dyspepsia
- Being tested
- DA-9701, DA-9701-R, DA-9701 Placebo, DA-9701-R Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-9701Drug
1 tablet, TID
DA-9701-RDrug
1 tablet, TID
DA-9701 PlaceboDrug
1 tablet, TID
DA-9701-R PlaceboDrug
1 tablet, TID
| Study group | Role | What they receive |
|---|---|---|
| DA-9701 | Experimental | administered for 4weeks(DA-9701 + DA-9701-R placebo) Receives: Drug: DA-9701; Drug: DA-9701-R Placebo |
| DA-9701-R | Active comparator | administered for 4weeks(DA-9701-R + DA-9701 placebo) Receives: Drug: DA-9701-R; Drug: DA-9701 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GIS(Gastrointestinal Symptom Score) total scores
Measured: Change from baseline at 4 weeks
Secondary outcomes (5)
Changes in GIS(Gastrointestinal Symptom Score) total scores
Measured: Change from baseline at 2 weeks
Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms
Measured: 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
Measured: Change from baseline at 4 weeks
Subject's global assessment
Measured: at week 4
Investigator's global assessment
Measured: at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start6 Aug 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686679
- Sponsor's protocol ID
- DA9701_FD_IV
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07686679
- Acronym / sponsor ID
- DA9701_FD_IV
- Conditions
- Functional Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-9701 | Experimental | Drug: DA-9701, Drug: DA-9701-R Placeboadministered for 4weeks(DA-9701 + DA-9701-R placebo) |
| DA-9701-R | Active comparator | Drug: DA-9701-R, Drug: DA-9701 Placeboadministered for 4weeks(DA-9701-R + DA-9701 placebo) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-97011 tablet, TID | Drug | DA-9701 |
| DA-9701-R1 tablet, TID | Drug | DA-9701-R |
| DA-9701 Placebo1 tablet, TID | Drug | DA-9701-R |
| DA-9701-R Placebo1 tablet, TID | Drug | DA-9701 |
Primary outcome
Changes in GIS(Gastrointestinal Symptom Score) total scores
Time frame: Change from baseline at 4 weeks
5 secondary outcomes
Changes in GIS(Gastrointestinal Symptom Score) total scores
Time frame: 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
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
Subject's global assessment
Time frame: at week 4
Investigator's global assessment
Time frame: at week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DA-9701 and DA-9701-R in people with Functional Dyspepsia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sang Kil Lee (+82) 02-2228-4000, SKLEE@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in GIS(Gastrointestinal Symptom Score) total scores (time frame: Change from baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.