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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Preventive Peptic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tegoprazan 25mg

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

Group Type EXPERIMENTAL

Tegoprazan 25 mg

Intervention Type DRUG

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

Lansoprazole 15mg

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

Group Type ACTIVE_COMPARATOR

Lansoprazole 15 mg

Intervention Type DRUG

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

Interventions

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Lansoprazole 15 mg

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

Intervention Type DRUG

Tegoprazan 25 mg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No