Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer

Launched by IL-YANG PHARM. CO., LTD. · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate how effective and safe a medication called Ilaprazole (10 mg) is in preventing peptic ulcers that can occur in patients taking NSAIDs (non-steroidal anti-inflammatory drugs), which are commonly used for pain relief. The study will compare Ilaprazole to another treatment to see if it works just as well in preventing these ulcers over a period of 24 weeks.

To participate in this trial, you need to be an adult (19 years or older) who is currently using NSAIDs for ongoing treatment and has certain risk factors for developing peptic ulcers. It's important to note that some individuals will not be eligible, including those with certain serious digestive issues or a recent history of certain cancers. If you qualify and decide to join the study, you'll be closely monitored by healthcare professionals to ensure your safety and the effectiveness of the treatment. This is a great opportunity to contribute to research that could help many people who rely on NSAIDs for pain management.

Gender

ALL

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