Actively Recruiting
Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
Led by Onconic Therapeutics Inc. · Updated on 2024-11-01
364
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female aged 19 years or older as of consent date
- Diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis requiring continuous NSAID use for 24 weeks or more
- Presence of one or more risk factors for ulcer development at screening
- Ability to understand and voluntarily sign the informed consent form
You will not qualify if you...
- Unable to undergo upper gastrointestinal endoscopy
- Presence of active or healing stage ulcers in stomach or duodenum at screening
- History of malignant tumor within the past 5 years
- History of symptoms suggesting malignant gastrointestinal disease
- Need for continuous use of corticosteroids, antiplatelet agents, or anticoagulants during the study (with some exceptions)
- Pregnant or breastfeeding women or positive pregnancy test at screening
- Participation in another study with investigational products or medical devices within 4 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Konkuk University Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
J
John KIM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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