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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07730138

Enrollment

384

Registered

2026-07-28

Start date

2026-10-15

Completion date

2028-10-15

Last updated

2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Ulcer

Keywords

DWP14012, Gastric Ulcer, P-CAB, peptic ulcer, stomach ulcer, duodenal ulcer

Brief 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

Interventions

DRUGDWP14012 40mg (Fexuprazan)

DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole

DRUGLansoprazole 30mg

Lansoprazole 30mg + Placebo of DWP14012 40mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-Blind

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

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 malignancy 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, refractory 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).

Design outcomes

Primary

Measure	Time frame
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8	Week 8

Secondary

Measure	Time frame
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4	Week 4
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 according to H. pylori infection status.	Week 4
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 according to H. pylori infection status.	Week 8
Changes in NDI scores at Weeks 4 and 8.	Week 4 and Week 8
Changes in the number of gastric ulcers at Weeks 4 and 8.	Week 4 and Week 8
Change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy	Week 4 and Week 8
Percentage change from baseline in gastric ulcer size assessed by upper gastrointestinal endoscopy at Week 4 and Week 8	Week 4 and Week 8

Countries

Indonesia, South Korea

Contacts

CONTACTHokyun Yoo

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026