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Active Not Recruiting
NCT06284876
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Conditions: Peptic Ulcer
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 416
Sponsor: Il-Yang Pharm. Co., Ltd.
Location: Chung Ang University Hospital Seoul
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 Criteria
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
Source: ClinicalTrials.gov (NCT06284876). StuddyBuddy aggregates publicly available trial information.