NCT04784910

Brief Summary

The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

March 3, 2021

Last Update Submit

July 3, 2024

Conditions

Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator

    at 24 weeks

Secondary Outcomes (2)

  • Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator

    at 12 weeks

  • Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24

    at 12, 24 weeks

Study Arms (2)

DWP14012 20mg

EXPERIMENTAL

orally, once daily

Drug: DWP14012 20mgDrug: Lansoprazole 15 mg placebo

Lansoprazole 15mg

ACTIVE COMPARATOR

orally, once daily

Drug: Lansoprazole 15 mgDrug: DWP14012 20mg placebo

Interventions

DWP14012 20mgDRUG

DWP14012 20mg, tablet, orally, once daily for up to 24 weeks

DWP14012 20mg
Lansoprazole 15 mgDRUG

Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks

Lansoprazole 15mg
DWP14012 20mg placeboDRUG

DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks

Lansoprazole 15mg
Lansoprazole 15 mg placeboDRUG

Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks

DWP14012 20mg

Eligibility Criteria

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

You may qualify if:

  • Male and female adults aged ≥ 19 years at the time of informed consent
  • Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
  • Subjects with at least one of the following risk factors for ulcer development at screening.
  • Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.

You may not qualify if:

  • Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
  • Subjects who have undergone gastroduodenal surgery or total small bowel resection
  • Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
  • Subjects who have had a malignant tumor in the last 5 years
  • Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Hong S, Ju JH, Lee SH, Hong SJ, Kim SH, Ahn GY, Jung JH, Hur JW, Ha YJ, Park JK, Kim HS, Lee SW, Park YB, Lim MJ, Kim YS, Song JS, Choi CB, Kim SH, Choi IA, Choi KD, Lee TH, Cho YS, Lee YC, Kwon KS, Lee H, Park M, Heo J, Baek S, Lee CK. Comparing the Efficacy and Safety of Fexuprazan and Lansoprazole for the Prevention of Nonsteroidal Anti-inflammatory Drug-Induced Peptic Ulcer. Gut Liver. 2025 Sep 15;19(5):685-695. doi: 10.5009/gnl250019. Epub 2025 Jun 26.

    PMID: 40567214DERIVED

MeSH Terms

Conditions

Peptic 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

May 21, 2021

Primary Completion

November 27, 2023

Study Completion

December 11, 2023

Last Updated

July 8, 2024

Record last verified: 2024-07

Locations

KR(1)