Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
NCT ID: NCT06439563
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
364 participants
INTERVENTIONAL
2024-10-22
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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JP-1366 10 mg
JP-1366 10 mg
JP-1366 10 mg, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg placebo
Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
Lanston Capsule 15 mg
Lanston Capsule 15 mg
Lanston Capsule 15 mg orally once a day for up to 24 weeks
JP-1366 10 mg placebo
JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks
Interventions
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JP-1366 10 mg
JP-1366 10 mg, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg
Lanston Capsule 15 mg orally once a day for up to 24 weeks
JP-1366 10 mg placebo
JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg placebo
Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
Eligibility Criteria
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Inclusion Criteria
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
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)
19 Years
ALL
No
Sponsors
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Onconic Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Konkuk University Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sang-Heon Lee
Role: primary
Other Identifiers
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JP-1366-304
Identifier Type: -
Identifier Source: org_study_id
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