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

JP-1366-304

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.

2024-08-01

2027-08-01

2027-12-01

Not yet recruiting

Early phase I

364

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 364, 'type': 'ESTIMATED'}}

2024-06-03