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RECRUITING
NCT06439563
PHASE3

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

Sponsor: Onconic Therapeutics Inc.

View on ClinicalTrials.gov

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

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

Locations (1)

Konkuk University Medical Center

Seoul, South Korea