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

Duodenal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208268
• Other study ID #: E3810-M082-520
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: September 22, 2022

Study information

• Verified date: January 2022
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Ulcer
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Pariet
Pariet Tablets.

Locations

Country	Name	City	State
Korea, Republic of	Site #09	Bucheon	Gyeongji-do
Korea, Republic of	Site #31	Bucheon	Gyeongji-do
Korea, Republic of	Site #07	Busan
Korea, Republic of	Site #08	Busan
Korea, Republic of	Site #14	Busan
Korea, Republic of	Site #15	Busan
Korea, Republic of	Site #28	Busan
Korea, Republic of	Site #20	Changwon	Gyeongsangnam-do
Korea, Republic of	Site #19	Cheongju	Chungcheongbuk-do
Korea, Republic of	Site #01	Chungju	Chungcheongbuk-do
Korea, Republic of	Site #02	Daegu
Korea, Republic of	Site #23	Daegu
Korea, Republic of	Site #27	Daegu
Korea, Republic of	Site #24	Dongtan	Gyeongji-do
Korea, Republic of	Site #29	Iksan	Jeollabuk-do
Korea, Republic of	Site #03	Ilsan	Gyeongji-do
Korea, Republic of	Site #11	Ilsan	Gyeongji-do
Korea, Republic of	Site #17	Incheon	Gyeongji-do
Korea, Republic of	Site #05	Seoul
Korea, Republic of	Site #06	Seoul
Korea, Republic of	Site #10	Seoul
Korea, Republic of	Site #13	Seoul
Korea, Republic of	Site #16	Seoul
Korea, Republic of	Site #18	Seoul
Korea, Republic of	Site #21	Seoul
Korea, Republic of	Site #22	Seoul
Korea, Republic of	Site #25	Seoul
Korea, Republic of	Site #26	Seoul
Korea, Republic of	Site #30	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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