NCT06439563

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 364 (estimated)
• Sponsor: Onconic Therapeutics Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peptic Ulcer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-22
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2024-06-03
• Last updated: 2024-11-01

Locations

1 site across 1 country: South Korea