Gastric UlcerPhase 3NCT07730138
Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer
A Phase 3 study testing DWP14012 40mg (Fexuprazan) and Lansoprazole 30mg in people with Gastric Ulcer, run by Daewoong Pharmaceutical Co. LTD. at 2 sites in 2 countries.
Trial summary
A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants with Gastric Ulcer Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- DWP14012 40mg (Fexuprazan) and Lansoprazole 30mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Oct 2026to 15 Oct 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter
- The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2.
Who cannot join
- Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion.
- Participants who, within 30 days prior to the screening visit (Visit 1), have undergone or are scheduled to undergo major surgery that may affect gastric acid secretion.
- Participants with a history of malignancy within 5 years prior to the screening visit (Visit 1); gastrointestinal malignancies are excluded regardless of the time elapsed.
- Participants who, at the screening visit (Visit 1), have gastrointestinal active bleeding , esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (> 3 cm), esophageal dysplasia, duodenal ulcer, refractory ulcer, perforated ulcer, or surgery-induced ulcer
- Participants who, at the screening visit (Visit 1), have pancreatitis or inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or intestinal Behçet's disease).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Indonesia1 site
RS Cipto Mangunkusumo
Jakarta
Rabbinu Rangga Pribadi, +82)550-8800, 2220160@daewoong.co.kr
South Korea1 site
The Catholic University of Korea, Incheon St. Mary'S Hospital
Incheon
Kim Byung-Wook, +82)550-8800, 2220160@daewoong.co.kr
About this study
Official title: A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants With Gastric Ulcer
A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants with Gastric Ulcer
- Conditions
- Gastric Ulcer
- Being tested
- DWP14012 40mg (Fexuprazan), Lansoprazole 30mg
- Keywords
- DWP14012, Gastric Ulcer, P-CAB, peptic ulcer, stomach ulcer, duodenal ulcer
- Medical subject headings
- Stomach Ulcer, Peptic Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 40mg (Fexuprazan)Drug
DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole
Lansoprazole 30mgDrug
Lansoprazole 30mg + Placebo of DWP14012 40mg
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Drug: DWP14012 40mg (Fexuprazan) |
| Control Group | Active comparator | Not described Receives: Drug: Lansoprazole 30mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8
Measured: Week 8
Secondary outcomes (7)
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4
Measured: Week 4
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 according to H. pylori infection status.
Measured: Week 4
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 according to H. pylori infection status.
Measured: Week 8
Changes in NDI scores at Weeks 4 and 8.
Measured: Week 4 and Week 8
Changes in the number of gastric ulcers at Weeks 4 and 8.
Measured: Week 4 and Week 8
Change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy
Measured: Week 4 and Week 8
Percentage change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy at Week 4 and Week 8
Measured: Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730138
- Sponsor's protocol ID
- DW_DWP14012315
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants With Gastric Ulcer
- ClinicalTrials.gov ID
- NCT07730138
- Acronym / sponsor ID
- DW_DWP14012315
- Conditions
- Gastric Ulcer
- Keywords
- DWP14012, Gastric Ulcer, P-CAB, peptic ulcer, stomach ulcer, duodenal ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 28 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.
A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants with Gastric Ulcer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: DWP14012 40mg (Fexuprazan) |
| Control Group | Active comparator | Drug: Lansoprazole 30mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter
- The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2.
Key exclusion criteria (5 listed)
- Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion.
- Participants who, within 30 days prior to the screening visit (Visit 1), have undergone or are scheduled to undergo major surgery that may affect gastric acid secretion.
- Participants with a history of malignancy within 5 years prior to the screening visit (Visit 1); gastrointestinal malignancies are excluded regardless of the time elapsed.
- Participants who, at the screening visit (Visit 1), have gastrointestinal active bleeding , esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (> 3 cm), esophageal dysplasia, duodenal ulcer, refractory ulcer, perforated ulcer, or surgery-induced ulcer
- Participants who, at the screening visit (Visit 1), have pancreatitis or inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or intestinal Behçet's disease).
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 |
|---|---|---|
| DWP14012 40mg (Fexuprazan)DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole | Drug | Study Group |
| Lansoprazole 30mgLansoprazole 30mg + Placebo of DWP14012 40mg | Drug | Control Group |
Primary outcome
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8
Time frame: Week 8
7 secondary outcomes
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4
Time frame: Week 4
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 according to H. pylori infection status.
Time frame: Week 4
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 according to H. pylori infection status.
Time frame: Week 8
Changes in NDI scores at Weeks 4 and 8.
Time frame: Week 4 and Week 8
Changes in the number of gastric ulcers at Weeks 4 and 8.
Time frame: Week 4 and Week 8
Change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy
Time frame: Week 4 and Week 8
Percentage change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy at Week 4 and Week 8
Time frame: Week 4 and Week 8
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWP14012 40mg (Fexuprazan) and Lansoprazole 30mg in people with Gastric Ulcer, run by Daewoong Pharmaceutical Co. LTD. at 2 sites in 2 countries.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia, 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?
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 Hokyun Yoo (+82)02-550-8800, 2220160@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 (time frame: Week 8). 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 28 Jul 2026.