Evaluating Ilaprazole for preventing NSAID-related peptic ulcers
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
This study is testing if Ilaprazole can help prevent stomach ulcers in adults who need to take NSAIDs regularly, comparing it to another medication called Lansoprazole.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 416 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Il-Yang Pharm. Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06284876 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of Ilaprazole 10 mg in preventing peptic ulcers associated with NSAID use. The study will compare Ilaprazole to an active control, Lansoprazole, to determine if it is non-inferior in preventing the occurrence of peptic ulcers over a 24-week period. Participants will include adults who require continuous NSAID treatment and have specific risk factors for peptic ulcers. The trial will involve random assignment to receive either Ilaprazole, Lansoprazole, or placebos.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years or older who are on continuous NSAID treatment and have risk factors for peptic ulcers.
Not a fit: Patients with severe gastrointestinal conditions or a history of malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective option for preventing NSAID-related peptic ulcers in at-risk patients.
How similar studies have performed: Previous studies have shown success with similar proton pump inhibitors in preventing NSAID-related ulcers, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul and 1 other locations
- Chung Ang University Hospital — Seoul, South Korea (Recruiting)
- Chung-Ang University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: JungSoo Song, M.D. — Chung-Ang University Hospital Center
- Study coordinator: JungHwa Hong, Master
- Email: jhhong@ilyang.co.kr
- Phone: +82.2.570.3777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.