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RecruitingPhase 3NCT06284876

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

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer

Sponsor

Il-Yang Pharm. Co., Ltd.

Enrollment

416 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Peptic Ulcer

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

Min Age: 19 Years

Inclusion Criteria4

  • Adult males and females aged 19 years or older on the day of informed consent
  • Subjects requiring continuous treatment or receiving treatment with NSAIDs
  • Subjects with at least one of following peptic ulcer risk factors at the time of Screening
  • Subjects who have provided voluntary informed consent for the study participation after the study is explained

Exclusion Criteria4

  • Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
  • Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
  • Subjects with confirmed history of malignancy within 5 years prior to Screening
  • Positive human immunodeficiency virus (HIV) antigen/antibody at Screening

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Interventions

DRUGIlaprazole

Ilaprazole 10 mg

DRUGLansoprazole

Lansoprazole 15 mg

DRUGIlaprazole Placebo

Placebo of Ilaprazole 10 mg

DRUGLansoprazole Placebo

Placebo of Lansoprazole 15 mg

Locations(2)

Chung Ang University Hospital

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

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NCT06284876

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