NCT07730138

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P50-P75 for phase_3

Timeline
24mo left

Started Oct 2026

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2028

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 1, 2026

Last Update Submit

July 22, 2026

Conditions

Gastric Ulcer

Keywords

DWP14012Gastric UlcerP-CABpeptic ulcerstomach ulcerduodenal ulcer

Outcome Measures

Primary Outcomes (1)

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

    Week 8

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Study Group

EXPERIMENTAL
Drug: DWP14012 40mg (Fexuprazan)

Control Group

ACTIVE COMPARATOR
Drug: Lansoprazole 30mg

Interventions

DWP14012 40mg (Fexuprazan)DRUG

DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole

Study Group
Lansoprazole 30mgDRUG

Lansoprazole 30mg + Placebo of DWP14012 40mg

Control Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

RS Cipto Mangunkusumo

Jakarta, Indonesia

Location

The Catholic University of Korea, Incheon St. Mary'S Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Stomach UlcerPeptic UlcerDuodenal Ulcer

Interventions

fexuprazanLansoprazole

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Hokyun Yoo

CONTACT

+82)02-550-88002220160@daewoong.co.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 28, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

October 15, 2028

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)ID(1)