Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142542 | Registry Identifier | JapicCTI | |
| JapicCTI-R160830 | Registry Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This survey was designed to evaluate the safety (that is, 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 with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.
For adults, 30 mg of lansoprazole is typically mixed in physiological saline (JP) or 5 percent (%) 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 mg of lansoprazole | 30 mg of lansoprazole is 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | Lansoprazole 30 mg injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
-
Not provided
Not provided
Not provided
Not provided
Acute stress ulcer and acute gastric mucosal lesions
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
Not provided
Participants with a historical diagnosis of acute stress ulcer or acute gastric mucosal lesion accompanied with bleeding, for whom oral administration of drug was not feasible were observed in a single treatment group to receive lansoprazole 30 milligrams (mg).
Participants took part in the study at 14 investigative site in Japan from 29 January 2007 to 31 March 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole | Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks . |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set was defined as all participants who were enrolled and completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lansoprazole | Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to Week 9 |
|
Baseline up to Week 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lansoprazole | Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks . |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D007267 | Injections |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline up to Week 9 |
| 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 |
| Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment | Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during 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 |
| 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 17 (8 weeks after the last dose of study drug) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pregnancy Status | This baseline characteristic was analyzed only in female participants. | Number | participants |
|
| Target Disease | This baseline characteristic was analyzed for participants who were suffering from disease being targeted in the study, which were acute stress-induced ulcer and acute gastric mucosal lesion. | Number | participants |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. This baseline characteristic was analyzed for inpatient participants. | Number | participants |
|
| Predisposition to Hypersensitivity | This baseline measure was analyzed in participants who had a tendency of suffering from hypersensitivity. | Number | participants |
|
| Helicobacter Pylori Infection | This baseline characteristic was analyzed in participants who tested either positive (had infection) or negative (did not have infection) for helicobacter pylori infection. | Number | participants |
|
| Alcohol consumption | Number | participants |
|
| Smoking | Number | participants |
|
| Medical History | Number | participants |
|
| Breakdown of Medical History | This baseline characteristic was analyzed in participants who had a medical history of peptic ulcer or upper gastrointestinal bleeding or cerebrovascular accident or malignant tumor or hepatic dysfunction or renal dysfunction or diabetes mellitus or cardiac disorders or hypertension or any other type of disease. Participants may be represented in more than 1 category. | Number | participants |
|
| Medical Complications | Number | participants |
|
| Breakdown of Complications | This baseline characteristic was analyzed in participants who had hypertension, cardiac disorders, diabetes mellitus, hepatic dysfunction, anemia, malignant tumor, cerebrovascular accident, renal dysfunction and any other medical complications. Participants may be represented in more than 1 category. | Number | participants |
|
| Emotional Stress | Number | participants |
|
| Breakdown of Drugs | The baseline characteristic was analyzed in participants who consumed non steroidal anti-inflammatory drugs, platelet aggregation inhibitors, anticoagulants, and steroids that affected the coagulation system during the month prior to administration of study drug. Participants may be represented in more than 1 category. | Number | participants |
|
| Prior Consumption of Drugs Affecting Coagulation System | The baseline characteristic was analyzed in participants who consumed drugs that affected the coagulation system during the month prior to administration of study drug. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | percentage of participants | Baseline up to Week 9 |
|
|
|
| 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. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | percentage of participants | Baseline up to Week 9 |
|
|
|
| Secondary | Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment | Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during 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. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | percentage of participants | Baseline up to Week 9 |
|
|
|
| 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. | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Number | percentage of participants | Week 17 (8 weeks after the last dose of study drug) |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |