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NCT Number: NCT07730138

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RS Cipto Mangunkusumo, Jakarta, Indonesia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

DWP14012 40mg (Fexuprazan)

Drug

DWP14012 40mg(Fexuprazan) + placebo of Lansoprazole

Lansoprazole 30mg

Drug

Lansoprazole 30mg + Placebo of DWP14012 40mg

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hokyun Yoo

CONTACT

[email protected]

+82)02-550-8800

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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