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

NCT ID: NCT05208268

Last Updated: 2022-11-22

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

COMPLETED

Total Enrollment

676 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-23

Study Completion Date

2022-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Stomach Ulcer Duodenal Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pariet

Participants with gastric and duodenal ulcer being administered with Pariet 5 mg, tablet within the scope of the approved label for Korea under the medical judgment of the investigator will be observed up to maximum of 24 weeks.

Pariet

Intervention Type DRUG

Pariet Tablets.

Interventions

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Pariet

Pariet Tablets.

Intervention Type DRUG

Other Intervention Names

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Rabeprazole Sodium

Eligibility Criteria

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Inclusion Criteria

1. Participants aged over 18 years
2. Participants who have a history of gastric and duodenal ulcer falling under the approved indication for Pariet Tablet 5 mg and who are receiving Pariet Tablet 5 mg to prevent gastric and duodenal ulcer from low dose aspirin use of 100 mg or less daily
3. Participants whose prescription of Pariet Tablet 5 mg has been determined before study participation
4. Participants who have given written consent to the use of their personal and medical information

Exclusion Criteria

1. Participants with a known hypersensitivity to rabeprazole sodium, any excipients used in the formulation or benzimidazole derivatives, and with the history of such hypersensitivity
2. Participants administered with atazanavir
3. Pregnant or lactating
4. Participants administered with rilpivirine
5. Participants currently participating in other clinical trials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site #09

Bucheon-si, Gyeongji-do, South Korea

Site Status

Site #31

Bucheon-si, Gyeongji-do, South Korea

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Site #24

Dongtan, Gyeongji-do, South Korea

Site Status

Site #03

Ilsan, Gyeongji-do, South Korea

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Site #11

Ilsan, Gyeongji-do, South Korea

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Site #17

Incheon, Gyeongji-do, South Korea

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Site #20

Changwon, Gyeongsangnam-do, South Korea

Site Status

Site #29

Iksan, Jeollabuk-do, South Korea

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Site #19

Cheongju-si, North Chungcheong, South Korea

Site Status

Site #01

Chungju, North Chungcheong, South Korea

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Site #07

Busan, , South Korea

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Site #08

Busan, , South Korea

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Site #14

Busan, , South Korea

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Site #15

Busan, , South Korea

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Site #28

Busan, , South Korea

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Site #02

Daegu, , South Korea

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Site #23

Daegu, , South Korea

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Site #27

Daegu, , South Korea

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Site #05

Seoul, , South Korea

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Site #06

Seoul, , South Korea

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Site #10

Seoul, , South Korea

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Site #13

Seoul, , South Korea

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Site #16

Seoul, , South Korea

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Site #18

Seoul, , South Korea

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Site #21

Seoul, , South Korea

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Site #22

Seoul, , South Korea

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Site #25

Seoul, , South Korea

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Site #26

Seoul, , South Korea

Site Status

Site #30

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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E3810-M082-520

Identifier Type: -

Identifier Source: org_study_id

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