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Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs

NCT04840550 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2023-07-14

No results posted yet for this study

Summary

This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.

Conditions

  • Preventive Peptic Ulcer

Interventions

DRUG

Lansoprazole 15 mg

Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

DRUG

Tegoprazan 25 mg

Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Jea Jun Kim · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2024-06-30
Completion
2024-07-31

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 NCT04840550 on ClinicalTrials.gov