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Recruiting Phase 3

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

NCT06439563 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2024-10-22
Last updated
2024-11-01

Condition(s) studied

Peptic Ulcer

Investigational drug(s) / intervention(s)

JP-1366 10 mgLanston Capsule 15 mgJP-1366 10 mg placeboLanston Capsule 15 mg placebo

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

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Cumulative proportion of subjects who developed peptic ulcers — at 24 weeks after administration of investigational products

Trial sites (1)

FacilityCityRegionStatus
Konkuk University Medical Center Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06439563 on ClinicalTrials.gov ↗ ← All trials in South Korea