Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers

Launched by ONCONIC THERAPEUTICS INC. · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called JP-1366 to see if it can effectively prevent peptic ulcers that can occur from taking nonsteroidal anti-inflammatory drugs (NSAIDs), commonly used for pain and inflammation. The researchers want to find out if JP-1366 is as effective as another medication, Lanston Capsule, in preventing these ulcers. The trial is currently recruiting participants who are adults aged 19 and older and have certain conditions like arthritis that require long-term use of NSAIDs.

To participate, individuals must have a higher risk of developing ulcers and be able to provide informed consent. However, those with active ulcers, certain gastrointestinal issues, recent histories of cancer, or specific health conditions may not be eligible. Participants can expect to receive the study medication and will be monitored for their health throughout the trial. This study aims to ensure that JP-1366 is both safe and effective for preventing NSAID-induced ulcers, which is important for patients who need to take these pain-relief medications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult male/female aged 19 years or older as of the date of obtaining consent
• • 2. Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more
• • 3. Those with one or more of the following risk factors for ulcer development at the time of screening
• • 4. Subjects who fully understand this study and voluntarily signed the informed consent form.
• Exclusion Criteria:
• • 1. Those who cannot undergo upper gastrointestinal endoscopy
• • 2. At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification\*
• • 3. Those with a confirmed history of malignant tumor within 5 years
• • 4. Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
• 5. Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
• • 6. Pregnant and lactating women or those with a positive pregnancy test result at screening
• • 7. Those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(Visit 0)