About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ilaprazole
- Lansoprazole
- Ilaprazole Placebo
- Lansoprazole Placebo