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Clinical Trials in South Korea / NCT06284876
Recruiting Phase 3

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

NCT06284876 · tracked via the Priya Life Science South Korea tracker
Sponsor
Il-Yang Pharm. Co., Ltd
Phase
Phase 3
Started
2024-07-23
Last updated
2025-05-30

Condition(s) studied

Peptic Ulcer

Investigational drug(s) / intervention(s)

IlaprazoleLansoprazole →Ilaprazole PlaceboLansoprazole Placebo

Ilaprazole: Ilaprazole 10 mg

Lansoprazole: Lansoprazole 15 mg

Ilaprazole Placebo: Placebo of Ilaprazole 10 mg

Lansoprazole Placebo: Placebo of Lansoprazole 15 mg

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult males and females aged 19 years or older on the day of informed consent 2. Subjects requiring continuous treatment or receiving treatment with NSAIDs 3. Subjects with at least one of following peptic ulcer risk factors at the time of Screening 4. Subjects who have provided voluntary informed consent for the study participation after the study is explained Exclusion Criteria: 1. Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results. 2. Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder 3. Subjects with confirmed history of malignancy within 5 years prior to Screening 4. Positive human immunodeficiency virus (HIV) antigen/antibody at Screening

Primary outcome measure(s)

  • Ilaprazole, Lansoprazole peptic ulcer — at 24 weeks
    Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment

Trial sites (2)

FacilityCityRegionStatus
Chung Ang University Hospital Seoul South Korea Recruiting
Chung-Ang University Hospital Seoul South Korea Recruiting

More Il-Yang Pharm. Co., Ltd. trials in South Korea

Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML Active, not recruiting
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs Recruiting
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers Recruiting

Other trials for the same condition

Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers Recruiting
Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06284876 on ClinicalTrials.gov ↗ ← All trials in South Korea