Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JP-1366 10 mg, Lanston Capsule 15 mg, JP-1366 10 mg placebo, Lanston Capsule 15 mg placebo.
- Who it may be relevant to
- Registry conditions: Peptic Ulcer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug JP-1366 10 mg
JP-1366 10 mg, tablet, orally once a day for up to 24 weeks - Drug Lanston Capsule 15 mg
Lanston Capsule 15 mg orally once a day for up to 24 weeks - Drug JP-1366 10 mg placebo
JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks - Drug Lanston Capsule 15 mg placebo
Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
Primary outcome measures
- Cumulative proportion of subjects who developed peptic ulcers [Time frame: at 24 weeks after administration of investigational products]
Secondary outcome measures (1)
- Proportion of subjects with gastric or duodenal endoscopic bleeding [Time frame: at 24 weeks after administration of investigational products]
Eligibility criteria
Inclusion criteria
- Adult male/female aged 19 years or older as of the date of obtaining consent
- 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
- Those with one or more of the following risk factors for ulcer development at the time of screening
- Subjects who fully understand this study and voluntarily signed the informed consent form.
Exclusion criteria
- Those who cannot undergo upper gastrointestinal endoscopy
- 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\*
- Those with a confirmed history of malignant tumor within 5 years
- Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
- Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
- Pregnant and lactating women or those with a positive pregnancy test result at screening
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Konkuk University Medical Center — Seoul
Identifiers
NCT: NCT06439563 · JP-1366-304