Clinical trial NCT02151786: Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
Official title: Takepron Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 1120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesions

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to Week 9
measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions
timeFrame: Baseline up to Week 9
Secondary outcomes:
measure: Percentage of Participants With Observed Hemostatic Effect
timeFrame: Baseline up to Week 9
measure: Percentage of Participants With Confirmed Hemostatic Effect
timeFrame: Baseline up to Week 9
measure: Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect
timeFrame: Baseline up to Week 9
measure: Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect
timeFrame: Baseline up to Week 9
measure: Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
timeFrame: Week 8 after the last dose of study drug (Week 17)
measure: Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
timeFrame: Week 8 after the last dose of study drug (Week 17)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: