Functional DyspepsiaPhase 3NCT05842408
Clinical Trial of DA-5212 in Patients with Functional Dyspepsia
A Phase 3 study testing DA-5212 and DA-5212-R in people with Functional Dyspepsia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- DA-5212 and DA-5212-R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jun 2023to 4 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥ 19 years of age
- Patients who diagnosed with functional dyspepsia
- Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit
Who cannot join
- Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit
- Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit
- Patients with hypersensitivity to investigational drugs and similar drugs
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients with Functional Dyspepsia
This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia
- Conditions
- Functional Dyspepsia
- Being tested
- DA-5212, DA-5212-R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5212Drug
Test drug: DA-5212
DA-5212-RDrug
Control drug: DA-5212-R
| Study group | Role | What they receive |
|---|---|---|
| DA-5212 | Experimental | administered once daily for 4weeks Receives: Drug: DA-5212 |
| DA-5212-R | Other | administered once daily for 4weeks Receives: Drug: DA-5212-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NDI-K functional dyspepsia score
Measured: Change from baseline at 4 weeks
Secondary outcomes (1)
Change in overall treatment score of patients
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start6 Jun 2023
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 384 participants (actual)
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
- NCT05842408
- Sponsor's protocol ID
- DA5212_FDQ_III
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients with Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05842408
- Acronym / sponsor ID
- DA5212_FDQ_III
- Conditions
- Functional Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 6 May 2023 (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 is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-5212 | Experimental | Drug: DA-5212administered once daily for 4weeks |
| DA-5212-R | Other | Drug: DA-5212-Radministered once daily for 4weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women ≥ 19 years of age
- Patients who diagnosed with functional dyspepsia
- Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit
Key exclusion criteria (4 listed)
- Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit
- Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit
- Patients with hypersensitivity to investigational drugs and similar drugs
- Pregnant or breastfeeding women
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-5212Test drug: DA-5212 | Drug | DA-5212 |
| DA-5212-RControl drug: DA-5212-R | Drug | DA-5212-R |
Primary outcome
Change in NDI-K functional dyspepsia score
Time frame: Change from baseline at 4 weeks
1 secondary outcome
Change in overall treatment score of patients
Time frame: Change from baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-5212 and DA-5212-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?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Dec 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NDI-K functional dyspepsia score (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 13 Dec 2024.