Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions Clinical Trial
Official title:
Takepron Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
| Verified date | January 2016 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1120 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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: |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Baseline up to Week 9 | Yes |
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Week 9 | Yes |
| Secondary | Percentage of Participants With Observed Hemostatic Effect | Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect. | Baseline up to Week 9 | No |
| Secondary | Percentage of Participants With Confirmed Hemostatic Effect | Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect. | Baseline up to Week 9 | No |
| Secondary | Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect | Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis. | Baseline up to Week 9 | No |
| Secondary | Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect | Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. | Baseline up to Week 9 | No |
| Secondary | Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment | Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis. | Week 8 after the last dose of study drug (Week 17) | No |
| Secondary | Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment | Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. | Week 8 after the last dose of study drug (Week 17) | No |