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Not yet recruitingNCT07730138Updated Jul 28, 2026

Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer

A Phase 3 interventional study of DWP14012 40mg (Fexuprazan) and Lansoprazole 30mg in Gastric Ulcer, sponsored by Daewoong Pharmaceutical Co. LTD.. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
384
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Gastric Ulcer

Keywords

  • DWP14012
  • Gastric Ulcer
  • P-CAB
  • peptic ulcer
  • stomach ulcer
  • duodenal ulcer
03

In context

Stomach Ulcer

116 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's planned enrollment of 384 is above the median of 298 across 88 interventional studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter
  2. The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2.

Exclusion criteria

Exclusion Criteria:

  1. Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion.
  2. 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.
  3. Participants with a history of within 5 years prior to the screening visit (Visit 1); gastrointestinal malignancies are excluded regardless of the time elapsed.
  4. 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, ulcer, perforated ulcer, or surgery-induced ulcer
  5. 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
384 participants (estimated)

Study arms

  • Experimental
    Study Group

    Drug: DWP14012 40mg (Fexuprazan)

  • Active comparator
    Control Group

    Drug: Lansoprazole 30mg

Interventions

06

What researchers measure

Primary outcomes

  1. Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8

    Time frame: Week 8

Secondary outcomes

  1. Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4

    Time frame: Week 4

  2. Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 according to H. pylori infection status.

    Time frame: Week 4

  3. Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 according to H. pylori infection status.

    Time frame: Week 8

  4. Changes in NDI scores at Weeks 4 and 8.

    Time frame: Week 4 and Week 8

  5. Changes in the number of gastric ulcers at Weeks 4 and 8.

    Time frame: Week 4 and Week 8

  6. Change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy

    Time frame: Week 4 and Week 8

  7. 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

07

Study locations

2 sites
  • RS Cipto Mangunkusumo
    Jakarta, Indonesia
  • The Catholic University of Korea, Incheon St. Mary'S Hospital
    Incheon, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07730138
Responsible party
Sponsor
First posted
Jul 28, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Apr 15, 2028 (estimated)
Completion
Oct 15, 2028 (estimated)
Last update
Jul 28, 2026

Study contacts

Hokyun Yoo
Contact
2220160@daewoong.co.kr
+82)02-550-8800

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Fexuprazan

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