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A Study of Pariet to Prevent Gastric and Duodenal Ulcer Associated With Low-aspirin in Korean Participants With a History of Gastric and Duodenal Ulcer

NCT05208268 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 676

Last updated 2022-11-22

No results posted yet for this study

Summary

The purpose of this study is to understand the following safety related particulars associated with the use of Pariet Tablet 5 milligram (mg) to prevent gastric and duodenal ulcer from low dose aspirin administration of 100 mg or less daily in participants with a history of gastric and duodenal ulcer: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.

Conditions

  • Stomach Ulcer
  • Duodenal Ulcer

Interventions

DRUG

Pariet

Pariet Tablets.

Sponsors & Collaborators

  • Eisai Korea Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-23
Primary Completion
2022-09-22
Completion
2022-09-22
FDA Drug
Yes

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 NCT05208268 on ClinicalTrials.gov