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

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.

Study Overview

• Status: Completed
• Conditions: Duodenal Ulcer; Stomach Ulcer
• Intervention / Treatment: Drug: Pariet

• Study Type: Observational
• Enrollment (Actual): 676

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with gastric and duodenal ulcer who have been administered with Pariet 5 mg will be enrolled in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Pariet; Pariet Tablets.; Other Names: Rabeprazole Sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Stomach Ulcer; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: E3810-M082-520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No