Acute Stress Ulcer and Acute Gastric Mucosal Lesions
Conditions
Keywords
Pharmacological therapy
Brief 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.
Detailed description
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.
Interventions
DRUGLansoprazole
Lansoprazole 30 mg injection
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to Week 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment | Week 17 (8 weeks after the last dose of study drug) | 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. |
| Percentage of Participants With Observed Hemostatic Effect | Baseline up to Week 9 | 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. |
| Percentage of Participants With Confirmed Hemostatic Effect | Baseline up to Week 9 | 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. |
| Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment | Baseline up to Week 9 | 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. |
Participant flow
Recruitment details
Participants took part in the study at 14 investigative site in Japan from 29 January 2007 to 31 March 2010.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 . | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case report forms unavailable | 5 |
Baseline characteristics
| Characteristic | Lansoprazole |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 16.41 |
| Alcohol consumption Alcohol Consumer | 15 participants |
| Alcohol consumption Alcohol Non-Consumer | 38 participants |
| Alcohol consumption Unknown | 5 participants |
| Breakdown of Complications Anemia | 4 participants |
| Breakdown of Complications Cardiac disorders | 4 participants |
| Breakdown of Complications Cerebrovascular accident | 1 participants |
| Breakdown of Complications Diabetes mellitus | 5 participants |
| Breakdown of Complications Hepatic dysfunction | 3 participants |
| Breakdown of Complications Hypertension | 8 participants |
| Breakdown of Complications Malignant tumor | 2 participants |
| Breakdown of Complications Other | 18 participants |
| Breakdown of Complications Renal dysfunction | 1 participants |
| Breakdown of Drugs Anticoagulants | 3 participants |
| Breakdown of Drugs Non Steroidal Anti-Inflammatory Drugs | 7 participants |
| Breakdown of Drugs Other | 1 participants |
| Breakdown of Drugs Platelet aggregation inhibitors | 5 participants |
| Breakdown of Drugs Steroids | 0 participants |
| Breakdown of Medical History Cardiac disorders | 2 participants |
| Breakdown of Medical History Cerebrovascular accident | 4 participants |
| Breakdown of Medical History Diabetes mellitus | 2 participants |
| Breakdown of Medical History Hepatic dysfunction | 3 participants |
| Breakdown of Medical History Hypertension | 0 participants |
| Breakdown of Medical History Malignant tumor | 3 participants |
| Breakdown of Medical History Other | 11 participants |
| Breakdown of Medical History Peptic ulcer | 13 participants |
| Breakdown of Medical History Renal dysfunction | 0 participants |
| Breakdown of Medical History Upper gastrointestinal bleeding | 1 participants |
| Emotional Stress Had no Stress | 29 participants |
| Emotional Stress Had Stress | 29 participants |
| Healthcare Category | 58 participants |
| Helicobacter Pylori Infection Negative | 16 participants |
| Helicobacter Pylori Infection Positive | 20 participants |
| Helicobacter Pylori Infection Unknown | 22 participants |
| Medical Complications Had Complications | 28 participants |
| Medical Complications Had no Complications | 30 participants |
| Medical History Did not have medical history | 28 participants |
| Medical History Had medical history | 30 participants |
| Predisposition to Hypersensitivity No | 54 participants |
| Predisposition to Hypersensitivity Yes | 4 participants |
| Pregnancy Status Not pregnant | 22 participants |
| Pregnancy Status Pregnant | 0 participants |
| Prior Consumption of Drugs Affecting Coagulation System Had consumption | 12 participants |
| Prior Consumption of Drugs Affecting Coagulation System Had no consumption | 46 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 36 Participants |
| Smoking Non-Smoker | 40 participants |
| Smoking Smoker | 14 participants |
| Smoking Unknown | 4 participants |
| Target Disease Acute Gastric Mucosal Lesion | 12 participants |
| Target Disease Acute Stress-Induced Ulcer | 46 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
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.
Time frame: Baseline up to Week 9
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole | Number of Participants Reporting One or More Adverse Drug Reactions | 0 participants |
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.
Time frame: Baseline up to Week 9
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole | Percentage of Participants With Confirmed Hemostatic Effect | 95.6 percentage of participants |
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.
Time frame: Week 17 (8 weeks after the last dose of study drug)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole | Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment | 0 percentage of participants |
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.
Time frame: Baseline up to Week 9
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole | Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment | 0 percentage of 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.
Time frame: Baseline up to Week 9
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole | Percentage of Participants With Observed Hemostatic Effect | 96.6 percentage of participants |