Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin

Detailed Description
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This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving low-dose aspirin. The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Official Title
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Takepron Capsules 15/ Orally Dispersing (OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

Conditions
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Gastric or Duodenal Ulcers

Intervention / Treatment
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* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole) Exclusion Criteria: (1) Patients with gastric or duodenal ulcer (in the active [A1, A2] or healing [H1, H2] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lansoprazole 15 mg<br>Lansoprazole 15 mg orally once daily | Drug: Lansoprazole<br>* Lansoprazole Capsules 15/ OD Tablets<br>* Other names: Takepron Capsules 15/ OD Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Drug Reactions | Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or Absence of Endoscopic Examinations | Summary of data on the presence or absence of endoscopic examinations. | From baseline to 12 months | 
| Presence of Gastric or Duodenal Ulcer | Summary of data on the presence or absence of gastric or duodenal ulcers. | From baseline to 12 months | 
| Presence of Gastric or Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions. | From baseline to 12 months | 
| Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion. | From baseline to 12 months | 
| Treatment for Gastric/Duodenal Ulcer or Lesion | Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions. | From baseline to 12 months | 
| Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. | From baseline to 12 months | 
| Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. | From baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacological therapy