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
1 other identifier
observational
676
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2020
CompletedFirst Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2022
CompletedNovember 22, 2022
January 1, 2022
2.2 years
January 13, 2022
November 21, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
Percentage of Participants With SAEs
SAEs is defined as any untoward medical occurrence: resulting in death; life threatening condition requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or occurrence of other medically significant events that need treatment such as drug dependency or abuse, blood disease.
Up to Week 24
Percentage of Participants With ADRs
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADR.
Up to Week 24
Percentage of Participants With Unexpected AEs
An AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results), symptoms, or diseases occurring during administration of drug, which do not necessarily have a causal relationship with the drug in question. An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug.
Up to Week 24
Percentage of Participants With Unexpected ADRs
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug.
Up to Week 24
Percentage of Participants With Already Known ADRs
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADR. Already known ADRs are those listed in product licensure/notification of the drug.
Up to Week 24
Percentage of Participants With Non-serious ADRs
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADRs.
Up to Week 24
Percentage of Participants with Final Effectiveness Evaluation
Participants assessed for final effectiveness after first dose of drug will be categorized into four categories: Improved, Unchanged, Worsened, and Unknown.
Up to Week 24
Study Arms (1)
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.
Interventions
Eligibility Criteria
Participants with gastric and duodenal ulcer who have been administered with Pariet 5 mg will be enrolled in the study.
You may qualify if:
- Participants aged over 18 years
- 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
- Participants whose prescription of Pariet Tablet 5 mg has been determined before study participation
- Participants who have given written consent to the use of their personal and medical information
You may not qualify if:
- Participants with a known hypersensitivity to rabeprazole sodium, any excipients used in the formulation or benzimidazole derivatives, and with the history of such hypersensitivity
- Participants administered with atazanavir
- Pregnant or lactating
- Participants administered with rilpivirine
- Participants currently participating in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Korea Inc.lead
Study Sites (29)
Site #09
Bucheon-si, Gyeongji-do, South Korea
Site #31
Bucheon-si, Gyeongji-do, South Korea
Site #24
Dongtan, Gyeongji-do, South Korea
Site #03
Ilsan, Gyeongji-do, South Korea
Site #11
Ilsan, Gyeongji-do, South Korea
Site #17
Incheon, Gyeongji-do, South Korea
Site #20
Changwon, Gyeongsangnam-do, South Korea
Site #29
Iksan, Jeollabuk-do, South Korea
Site #19
Cheongju-si, North Chungcheong, South Korea
Site #01
Chungju, North Chungcheong, South Korea
Site #07
Busan, South Korea
Site #08
Busan, South Korea
Site #14
Busan, South Korea
Site #15
Busan, South Korea
Site #28
Busan, South Korea
Site #02
Daegu, South Korea
Site #23
Daegu, South Korea
Site #27
Daegu, South Korea
Site #05
Seoul, South Korea
Site #06
Seoul, South Korea
Site #10
Seoul, South Korea
Site #13
Seoul, South Korea
Site #16
Seoul, South Korea
Site #18
Seoul, South Korea
Site #21
Seoul, South Korea
Site #22
Seoul, South Korea
Site #25
Seoul, South Korea
Site #26
Seoul, South Korea
Site #30
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2022
First Posted
January 26, 2022
Study Start
July 23, 2020
Primary Completion
September 22, 2022
Study Completion
September 22, 2022
Last Updated
November 22, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.