N/A
N=63
Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]
Acute Stress Ulcer and Acute Gastric Mucosal Lesions
Bottom Line
View on ClinicalTrials.gov: NCT02170207 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Participants Reporting One or More Adverse Drug Reactions — 0 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 |
— | — |
| SECONDARY Percentage of Participants With Observed Hemostatic Effect |
96.6 | — |
| SECONDARY Percentage of Participants With Confirmed Hemostatic Effect |
95.6 | — |
| SECONDARY Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment |
— | — |
| SECONDARY Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment |
— | — |
Summary
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.
Eligibility Criteria
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
-
Data sourced from ClinicalTrials.gov (NCT02170207). 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.