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

IY-NTNS03

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

2024-08-30

2026-08-30

2027-02-28

Not yet recruiting

Early phase I

416

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 416, 'type': 'ESTIMATED'}}

2024-02-29