Actively Recruiting

Phase 3
Age: 19Years +
All Genders
NCT06439563

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Konkuk University Medical Center

Seoul, South Korea

Actively Recruiting

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