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Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
Sponsor: Onconic Therapeutics Inc.
Summary
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.
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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2024-10-22
Completion Date
2027-12
Last Updated
2024-11-01
Healthy Volunteers
No
Conditions
Interventions
JP-1366 10 mg
JP-1366 10 mg, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg
Lanston Capsule 15 mg orally once a day for up to 24 weeks
JP-1366 10 mg placebo
JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg placebo
Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
Locations (1)
Konkuk University Medical Center
Seoul, South Korea