Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]

Takeda

Status: Completed

Conditions: Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions

Treatments: Drug: Lansoprazole

Study type: Observational

Funder types: Industry

Identifiers

NCT02151786

JapicCTI-142549 (Registry Identifier)

254-011

JapicCTI-R160829 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., 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 patients in daily medical practice.

Full description

This survey was designed to evaluate the safety (i.e., 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 in daily medical practice.

For adults, 30 mg of lansoprazole is typically 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.

Enrollment: 1,120 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with the following diseases for whom oral administration is not feasible:

Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesion (all of which should be accompanied by bleeding).

Exclusion criteria

Trial design

1,120 participants in 1 patient group

Thirty milligrams of lansoprazole

Description:

Thirty milligrams of lansoprazole is mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 milliliter (mL) of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.

Treatment:

Drug: Lansoprazole