Actively Recruiting
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg Compared to Lansoprazole 15 mg in Preventing NSAIDs-Associated Peptic Ulcer A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Trial
Led by Il-Yang Pharm. Co., Ltd. ยท Updated on 2025-05-30
416
Participants Needed
2
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Chung Ang University Hospital
Seoul, South Korea
Actively Recruiting
2
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
JungHwa Hong, Master
J
JeongSu Wi, bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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