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

NCT06439563 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2024-11-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Onconic Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2027-08-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439563 on ClinicalTrials.gov