Stomach UlcerNCT05208268
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
An observational study of Stomach Ulcer and Duodenal Ulcer, run by Eisai Korea Inc. at 29 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Ulcer, Duodenal Ulcer
- What is being tested?
- Pariet
- Type of treatment
- Pill or oral medicine
- How many people
- 676 participants
- Where
- 29 sitesSouth Korea
- Study dates
- 23 Jul 2020to 22 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with gastric and duodenal ulcer who have been administered with Pariet 5 mg will be enrolled in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
South Korea29 sites
Site #09
Bucheon-si, Gyeongji-do
Site #31
Bucheon-si, Gyeongji-do
Site #07
Busan
Site #08
Busan
Site #14
Busan
Site #15
Busan
Site #28
Busan
Site #20
Changwon, Gyeongsangnam-do
Site #19
Cheongju-si, North Chungcheong
Site #01
Chungju, North Chungcheong
Site #02
Daegu
Site #23
Daegu
Site #27
Daegu
Site #24
Dongtan, Gyeongji-do
Site #29
Iksan, Jeollabuk-do
Site #03
Ilsan, Gyeongji-do
Site #11
Ilsan, Gyeongji-do
Site #17
Incheon, Gyeongji-do
Site #05
Seoul
Site #06
Seoul
Site #10
Seoul
Site #13
Seoul
Site #16
Seoul
Site #18
Seoul
Site #21
Seoul
Site #22
Seoul
Site #25
Seoul
Site #26
Seoul
Site #30
Seoul
About this study
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
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.
- Conditions
- Stomach Ulcer, Duodenal Ulcer
- Being tested
- Pariet
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParietDrug
Also called Rabeprazole Sodium
Pariet Tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pariet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start23 Jul 2020
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208268
- Sponsor's protocol ID
- E3810-M082-520
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05208268
- Acronym / sponsor ID
- E3810-M082-520
- Conditions
- Stomach Ulcer, Duodenal Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pariet | – | Drug: ParietParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with gastric and duodenal ulcer who have been administered with Pariet 5 mg will be enrolled in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParietAlso: Rabeprazole SodiumPariet Tablets. | Drug | Pariet |
Primary outcome
Percentage of Participants With SAEs
Time frame: Up to Week 24
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.
Percentage of Participants With ADRs
Time frame: Up to Week 24
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.
Percentage of Participants With Unexpected AEs
Time frame: Up to Week 24
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.
Percentage of Participants With Unexpected ADRs
Time frame: Up to Week 24
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.
Percentage of Participants With Already Known ADRs
Time frame: Up to Week 24
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.
Percentage of Participants With Non-serious ADRs
Time frame: Up to Week 24
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.
Percentage of Participants with Final Effectiveness Evaluation
Time frame: Up to Week 24
Participants assessed for final effectiveness after first dose of drug will be categorized into four categories: Improved, Unchanged, Worsened, and Unknown.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Ulcer and Duodenal Ulcer, run by Eisai Korea Inc. at 29 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With SAEs (time frame: Up to Week 24). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.