NCT05208268

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

A Post-marketing Surveillance of Pariet Tab. 5 mg to Prevent Gastric and Duodenal Ulcer Associated With Low-aspirin, 100 mg or Less Daily, Administration in Korean Patients With a History of Gastric and Duodenal Ulcer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 676 (actual)
• Sponsor: Eisai Korea Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Pariet	Pariet Tablets.

Timeline

• Start date: 2020-07-23
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2022-01-26
• Last updated: 2022-11-22

Locations

29 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study