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Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Sponsor: Il-Yang Pharm. Co., Ltd.
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
Official title: 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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
416
Start Date
2024-07-23
Completion Date
2027-02-28
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Ilaprazole
Ilaprazole 10 mg
Lansoprazole
Lansoprazole 15 mg
Ilaprazole Placebo
Placebo of Ilaprazole 10 mg
Lansoprazole Placebo
Placebo of Lansoprazole 15 mg
Locations (2)
Chung Ang University Hospital
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea