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

Takeda

Status: Completed

Conditions: Acute Stress Ulcer and Acute Gastric Mucosal Lesions

Treatments: Drug: Lansoprazole

Study type: Observational

Funder types: Industry

Identifiers

NCT02170207

JapicCTI-142542 (Registry Identifier)

254-012

JapicCTI-R160830 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 63 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

63 participants in 1 patient group

30 mg of lansoprazole

Description:

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.

Treatment:

Drug: Lansoprazole