NCT06439563 Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
| NCT ID | NCT06439563 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Onconic Therapeutics Inc. |
| Condition | Peptic Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 364 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-08 |
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 364 participants in total. It began in 2024-10-22 with a primary completion date of 2027-08.
⚠ 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
The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06439563 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 NCT06439563 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 364 participants.
Is NCT06439563 currently recruiting?
Yes, NCT06439563 is actively recruiting participants. Contact the research team at onconictherapeutics@gmail.com for enrollment information.
Where is the NCT06439563 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06439563 clinical trial?
NCT06439563 is sponsored by Onconic Therapeutics Inc.. The trial plans to enroll 364 participants.