Evaluating JP-1366 for preventing NSAID-induced peptic ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of JP-1366 10 mg in preventing peptic ulcers caused by NSAIDs, comparing it to Lanston Capsule 15 mg. It is a Phase 3 interventional trial involving adult patients with musculoskeletal diseases who require long-term NSAID treatment. Participants will be randomly assigned to receive either JP-1366, Lanston Capsule, or placebos to evaluate the non-inferiority of JP-1366 in ulcer prevention.

Why it matters

Who can join: the full rules

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)

Where it's running

• Konkuk University Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: John KIM
• Email: onconictherapeutics@gmail.com
• Phone: 0234540780

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.