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

HK inno.N

Status and phase: Enrolling; Phase 3

Conditions: Preventive Peptic Ulcer

Treatments: Drug: Tegoprazan 25 mg; Drug: Lansoprazole 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04840550

IN_APA_308

Details and patient eligibility

About

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.

Full description

This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).

Enrollment: 390 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
• Requires continued treatment with NSAIDs for ≥24 weeks

Exclusion criteria

• Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
• Has uncontrolled severe hypertension
• Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
• Has a positive H. pylori test at screening

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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390 participants in 2 patient groups

Tegoprazan 25mg

Experimental group

Description:

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

Treatment:

Drug: Tegoprazan 25 mg

Lansoprazole 15mg

Active Comparator group

Description:

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

Treatment:

Drug: Lansoprazole 15 mg