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

HK inno.N Corporation392 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

392

Conditions

Preventive Peptic Ulcer

Interventions

Lansoprazole 15 mgDRUG

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

Tegoprazan 25 mgDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (2)

Samsung Medical Center

Seoul, South Korea

The catholic univ. of Korea Eunpyeong ST. Mari's hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of subjects with gastric and/or duodenal ulcers at Week 24

The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24

Time frame: week 24

Secondary Outcomes

Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24

GI symptoms are as follows; Heartburn, Regurgitation, Upper abdominal pain or discomfort

Time frame: week 4, 12, 24

Data from ClinicalTrials.gov

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