Evaluating JP-1366 for preventing NSAID-induced peptic ulcers
A Multicenter, Parallel, Double-blind, Randomized, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 Treatment in the Prevention of (NSAIDs)-Induced Peptic Ulcers
This study is testing if a new drug called JP-1366 can help prevent stomach ulcers in adults with musculoskeletal diseases who need to take pain relievers for a long time.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 364 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Onconic Therapeutics Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06439563 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with musculoskeletal diseases requiring long-term NSAID use and who have risk factors for ulcer development.
Not a fit: Patients with active or healing stage ulcers or those unable to undergo gastrointestinal endoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients at risk of NSAID-induced peptic ulcers.
How similar studies have performed: Previous studies have shown promise in similar approaches, but this specific evaluation of JP-1366 is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seoul
- Konkuk University Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: John KIM
- Email: onconictherapeutics@gmail.com
- Phone: 0234540780
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.