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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pariet | Drug | Pariet Tablets. |
|
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with gastric and duodenal ulcer who have been administered with Pariet 5 mg will be enrolled in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #09 | Bucheon-si | Gyeongji-do | South Korea | |||
| Site #31 |
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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| 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 |
| 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 |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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