N/A
N=1,120
Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions
Bottom Line
View on ClinicalTrials.gov: NCT02151786 ↗Enrolled (actual)
1,120
Serious AEs
0.8%
Results posted
Feb 2016
Primary outcome: Primary: Number of Participants Reporting One or More Adverse Drug Reactions — 35 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lansoprazole (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions |
35 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
9 | — |
| SECONDARY Percentage of Participants With Observed Hemostatic Effect |
90.3 | — |
| SECONDARY Percentage of Participants With Confirmed Hemostatic Effect |
91.6 | — |
| SECONDARY Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect |
1.1 | — |
| SECONDARY Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect |
1.2 | — |
| SECONDARY Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment |
5.8 | — |
| SECONDARY Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment |
7.1 | — |
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.
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
-
Data sourced from ClinicalTrials.gov (NCT02151786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.