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Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer

NCT06284876 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2025-05-30

No results posted yet for this study

Summary

To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24

Conditions

  • Peptic Ulcer

Interventions

DRUG

Ilaprazole

Ilaprazole 10 mg

DRUG

Lansoprazole

Lansoprazole 15 mg

DRUG

Ilaprazole Placebo

Placebo of Ilaprazole 10 mg

DRUG

Lansoprazole Placebo

Placebo of Lansoprazole 15 mg

Sponsors & Collaborators

  • Il-Yang Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • JungSoo Song, M.D. · Chung-Ang University Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-23
Primary Completion
2026-08-30
Completion
2027-02-28

Countries

  • South Korea

Study Locations

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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 NCT06284876 on ClinicalTrials.gov