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

Onconic Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Peptic Ulcer

Treatments: Drug: JP-1366 10 mg; Drug: Lanston Capsule 15 mg; Drug: Lanston Capsule 15 mg placebo; Drug: JP-1366 10 mg placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06439563

JP-1366-304

Details and patient eligibility

About

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.

Enrollment: 364 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 2 patient groups

JP-1366 10 mg

Experimental group

Treatment:

Drug: Lanston Capsule 15 mg placebo

Drug: JP-1366 10 mg

Lanston Capsule 15 mg

Active Comparator group

Treatment:

Drug: JP-1366 10 mg placebo

Drug: Lanston Capsule 15 mg