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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142549 | Registry Identifier | JapicCTI | |
| JapicCTI-R160829 | Registry Identifier | JapicCTI |
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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.
This survey was designed 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 mg (Takepron Intravenous 30 mg) to a large number of participants in daily medical practice.
For adults, 30 mg of lansoprazole is typically 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thirty milligrams of lansoprazole | Thirty milligrams of lansoprazole is mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 milliliter (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 intravenous 30 mg |
|
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesion (all of which should be accompanied by bleeding).
Exclusion Criteria:
-
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Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesions
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
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In this study, participants were observed with a historical diagnosis of gastric ulcer or duodenal ulcer or acute stress ulcer or acute gastric mucosal lesion accompanied with bleeding, for whom oral administration of drug was not feasible and were enrolled in single treatment group: Lansoprazole.
Participants took part in the study at 173 investigative site in Japan from 29 January 2007 to 31 March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole | Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lansoprazole | Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 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.
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| 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 9 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 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 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 |
| 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 |
| 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) |
| 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) |
| Unavailability of Information |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pregnancy Status | This baseline characteristic was analysed only in female participants. | Number | participants |
|
| Target Diseases | Number of participants suffering from different types of ulcer in the study were described in this baseline measure. | Number | participants |
|
| Categories of Healthcare | Participants were categorized as outpatient and inpatient. | Number | participants |
|
| Predisposition to Hypersensitivity | Participants having tendency to suffer from hypersensitivity were classified in this baseline measure. | Number | participants |
|
| Helicobacter pylori Infection | Participants diagnosed as positive or negative Helicobacter pylori infection were described in this baseline measure. | Number | participants |
|
| Alcohol Consumption | Number | participants |
|
| Smoking Status | Number | participants |
|
| Medical History | Number | participants |
|
| Breakdown of Medical History | Participants having more than 1 disease were reported in multiple categories. | Number | participants |
|
| Complications | Number | participants |
|
| Breakdown of Complications | Number | participants |
|
| Emotional Stress | Number | participants |
|
| Prior Consumption of Drugs Affecting Coagulation System | The participants with history of consumption of drugs affecting the coagulation system 1 month prior to study treatment were reported in this baseline measure. | Number | participants |
|
| Breakdown of Drugs | The participants with history of consumption of drugs affecting the coagulation system were categorized in this baseline measure on the basis of drugs which they have taken. | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to Week 9 |
|
|
|
| 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 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. | 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 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. | 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 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. | 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 8 after the last dose of study drug (Week 17) |
|
|
|
| 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 8 after the last dose of study drug (Week 17) |
|
|
|
| 9 |
| 1,084 |
| 35 |
| 1,084 |
| Restlessness | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Depressive Symptom | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastric Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
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.
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |