Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ilaprazole, Lansoprazole, Ilaprazole Placebo, Lansoprazole Placebo.
- Who it may be relevant to
- Registry conditions: Peptic Ulcer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug Ilaprazole
Ilaprazole 10 mg - Drug Lansoprazole
Lansoprazole 15 mg - Drug Ilaprazole Placebo
Placebo of Ilaprazole 10 mg - Drug Lansoprazole Placebo
Placebo of Lansoprazole 15 mg
Primary outcome measures
- Ilaprazole, Lansoprazole peptic ulcer [Time frame: at 24 weeks]
Secondary outcome measures (2)
- Ilaprazole, Lansoprazole peptic ulcer [Time frame: at 12 weeks]
- Ilaprazole, Lansoprazole GI bleeding [Time frame: at 12, 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
South Korea · 2 centers
- Chung Ang University Hospital — Seoul
- Chung-Ang University Hospital — Seoul
Identifiers
NCT: NCT06284876 · IY-NTNS03