NCT06284876 Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
| NCT ID | NCT06284876 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Il-Yang Pharm. Co., Ltd. |
| Condition | Peptic Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 416 participants |
| Start Date | 2024-07-23 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 416 participants in total. It began in 2024-07-23 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
JungSoo Song, M.D.
PRINCIPAL INVESTIGATOR
Chung-Ang University Hospital Center
Frequently Asked Questions
Who can join the NCT06284876 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Peptic Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06284876 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 416 participants.
Is NCT06284876 currently recruiting?
Yes, NCT06284876 is actively recruiting participants. Contact the research team at jhhong@ilyang.co.kr for enrollment information.
Where is the NCT06284876 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06284876 clinical trial?
NCT06284876 is sponsored by Il-Yang Pharm. Co., Ltd.. The principal investigator is JungSoo Song, M.D. at Chung-Ang University Hospital Center. The trial plans to enroll 416 participants.