MedTrace Logo

Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

NCT04784910 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

  • Peptic Ulcer

Interventions

DRUG

DWP14012 20mg

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

DRUG

Lansoprazole 15 mg

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

DRUG

DWP14012 20mg placebo

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

DRUG

Lansoprazole 15 mg placebo

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

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2023-11-27
Completion
2023-12-11

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784910 on ClinicalTrials.gov