Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Ulcer
Duodenal Ulcer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With SAEs
timeFrame: Up to Week 24
measure: Percentage of Participants With ADRs
timeFrame: Up to Week 24
measure: Percentage of Participants With Unexpected AEs
timeFrame: Up to Week 24
measure: Percentage of Participants With Unexpected ADRs
timeFrame: Up to Week 24
measure: Percentage of Participants With Already Known ADRs
timeFrame: Up to Week 24
measure: Percentage of Participants With Non-serious ADRs
timeFrame: Up to Week 24
measure: Percentage of Participants with Final Effectiveness Evaluation
timeFrame: Up to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Site #19
state: Chungcheongbuk-do
city: Chungju
country: Korea, Republic of
facility: Site #01
state: Chungcheongbuk-do
city: Bucheon
country: Korea, Republic of
facility: Site #09
state: Gyeongji-do
city: Bucheon
country: Korea, Republic of
facility: Site #31
state: Gyeongji-do
city: Dongtan
country: Korea, Republic of
facility: Site #24
state: Gyeongji-do
city: Ilsan
country: Korea, Republic of
facility: Site #03
state: Gyeongji-do
city: Ilsan
country: Korea, Republic of
facility: Site #11
state: Gyeongji-do
city: Incheon
country: Korea, Republic of
facility: Site #17
state: Gyeongji-do
city: Changwon
country: Korea, Republic of
facility: Site #20
state: Gyeongsangnam-do
city: Iksan
country: Korea, Republic of
facility: Site #29
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Site #07
city: Busan
country: Korea, Republic of
facility: Site #08
city: Busan
country: Korea, Republic of
facility: Site #14
city: Busan
country: Korea, Republic of
facility: Site #15
city: Busan
country: Korea, Republic of
facility: Site #28
city: Daegu
country: Korea, Republic of
facility: Site #02
city: Daegu
country: Korea, Republic of
facility: Site #23
city: Daegu
country: Korea, Republic of
facility: Site #27
city: Seoul
country: Korea, Republic of
facility: Site #05
city: Seoul
country: Korea, Republic of
facility: Site #06
city: Seoul
country: Korea, Republic of
facility: Site #10
city: Seoul
country: Korea, Republic of
facility: Site #13
city: Seoul
country: Korea, Republic of
facility: Site #16
city: Seoul
country: Korea, Republic of
facility: Site #18
city: Seoul
country: Korea, Republic of
facility: Site #21
city: Seoul
country: Korea, Republic of
facility: Site #22
city: Seoul
country: Korea, Republic of
facility: Site #25
city: Seoul
country: Korea, Republic of
facility: Site #26
city: Seoul
country: Korea, Republic of
facility: Site #30
Study officials:
References: