Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]

Study Overview
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Brief Summary
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The purpose of this survey is to evaluate the safety (that is, frequency of adverse events) and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.

Detailed Description
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This survey was designed to evaluate the safety (that is, frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 mg (Takepron Intravenous 30 mg) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice. For adults, 30 mg of lansoprazole is typically mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.

Official Title
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Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]

Conditions
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Acute Stress Ulcer and Acute Gastric Mucosal Lesions

Intervention / Treatment
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* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Participants with the following diseases for whom oral administration is not feasible: Acute stress ulcer, and acute gastric mucosal lesions (both of which should be accompanied by bleeding). Exclusion Criteria: -
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 |
| --- | --- |
| 30 mg of lansoprazole<br>30 mg of lansoprazole is mixed in physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection. | Drug: Lansoprazole<br>* Lansoprazole 30 mg injection<br>* Other names: Takepron 30 mg Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting One or More Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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. | Baseline up to Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Observed Hemostatic Effect | Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect. | Baseline up to Week 9 | 
| Percentage of Participants With Confirmed Hemostatic Effect | Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect. | Baseline up to Week 9 | 
| Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment | Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. | Baseline up to Week 9 | 
| Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment | Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. | Week 17 (8 weeks after the last dose of study drug) | 

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