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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-03-31

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.

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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.

Conditions

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Acute Stress Ulcer and Acute Gastric Mucosal Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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30 mg of lansoprazole

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.

Lansoprazole

Intervention Type DRUG

Lansoprazole 30 mg injection

Interventions

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Lansoprazole

Lansoprazole 30 mg injection

Intervention Type DRUG

Other Intervention Names

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Takepron 30 mg Injection

Eligibility Criteria

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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).