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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 416
- Locations
- 2
- Primary Endpoint
- Ilaprazole, Lansoprazole peptic ulcer
Study Overview
Brief 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
Detailed Description
Not provided
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Ilaprazole 10 mg
Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.
Intervention: Ilaprazole (Drug)
Ilaprazole 10 mg
Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.
Intervention: Lansoprazole Placebo (Drug)
Lansoprazole 15 mg
Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.
Intervention: Lansoprazole (Drug)
Lansoprazole 15 mg
Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.
Intervention: Ilaprazole Placebo (Drug)
Outcomes
Primary Outcomes
Ilaprazole, Lansoprazole peptic ulcer
Time Frame: at 24 weeks
Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment
Secondary Outcomes
- Ilaprazole, Lansoprazole peptic ulcer(at 12 weeks)
- Ilaprazole, Lansoprazole GI bleeding(at 12, 24 weeks)