Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesions
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events (adverse drug reactions) Primary timeframe: Up to 9 weeks The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with lansoprazole are defined as adverse drug reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hemostatic effect 2. Rebleeding rate during treatment with Takepron 30 mg Injection 3. Rebleeding rate after the completion of treatment with Takepron Intravenous 30 mg Secondary timeframe: Up to 9 weeks from baseline 1. In patients for whom hemostasis is confirmed by endoscopy, the frequencies of hemostatic effects of Takepron 30 mg Injection are tabulated by the degree of improvement (i.e., "markedly improved," "moderately improved," "slightly improved," and "poor"). 2. In patients for whom hemostasis is confirmed by endoscopy performed after the start of treatment with Takepron Intravenous 30 mg, the rebleeding rates during the period starting from baseline until the completion of treatment with Takepron Intravenous 30 mg are tabulated. 3. In patients for whom hemostasis is confirmed by endoscopy, the rebleeding rates at 8 weeks after the completion of treatment with Takepron Intravenous 30 mg are tabulated. | — |
Outcome results
None listed