Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions
Conditions
Keywords
Pharmacological therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGLansoprazole
Lansoprazole intravenous 30 mg
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
\-
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. |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to Week 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect | Baseline up to Week 9 | 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. |
| Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect | Baseline up to Week 9 | 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. |
| 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 Who Experienced Rebleeding After the Completion of Treatment | Week 8 after the last dose of study drug (Week 17) | 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 Who Experienced Rebleeding After the Completion of Treatment | Week 8 after the last dose of study drug (Week 17) | 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. |
| 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. |
Participant flow
Recruitment details
Participants took part in the study at 173 investigative site in Japan from 29 January 2007 to 31 March 2010.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Lansoprazole Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks. | 1,084 |
| Total | 1,084 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Outside the Contract Period | 1 |
| Overall Study | Randomized, not Treated | 1 |
| Overall Study | Unavailability of Case Report Form | 26 |
| Overall Study | Unavailability of Information | 8 |
Baseline characteristics
| Characteristic | Lansoprazole |
|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 14.74 |
| Alcohol Consumption Alcohol Consumer | 382 participants |
| Alcohol Consumption Alcohol Non-Consumer | 547 participants |
| Alcohol Consumption Unknown | 155 participants |
| Breakdown of Complications Anemia | 78 participants |
| Breakdown of Complications Cardiac Disorders | 121 participants |
| Breakdown of Complications Cerebrovascular Accident | 66 participants |
| Breakdown of Complications Diabetes Mellitus | 118 participants |
| Breakdown of Complications Hepatic Dysfunction | 115 participants |
| Breakdown of Complications Hypertension | 206 participants |
| Breakdown of Complications Malignant Tumor | 68 participants |
| Breakdown of Complications Other | 351 participants |
| Breakdown of Complications Renal Dysfunction | 61 participants |
| Breakdown of Drugs Anticoagulants | 49 participants |
| Breakdown of Drugs Non Steroidal Anti-Inflammatory Drugs | 158 participants |
| Breakdown of Drugs Other | 17 participants |
| Breakdown of Drugs Platelet aggregation inhibitors | 152 participants |
| Breakdown of Drugs Steroids | 31 participants |
| Breakdown of Medical History Cardiac Disorders | 55 participants |
| Breakdown of Medical History Cerebrovascular accident | 64 participants |
| Breakdown of Medical History Diabetes Mellitus | 37 participants |
| Breakdown of Medical History Hepatic Dysfunction | 42 participants |
| Breakdown of Medical History Hypertension | 55 participants |
| Breakdown of Medical History Malignant Tumor | 59 participants |
| Breakdown of Medical History Other | 187 participants |
| Breakdown of Medical History Peptic Ulcer | 241 participants |
| Breakdown of Medical History Renal Dysfunction | 13 participants |
| Breakdown of Medical History Upper gastrointestinal bleeding | 97 participants |
| Categories of Healthcare Inpatient | 1073 participants |
| Categories of Healthcare Outpatient | 11 participants |
| Complications Had Complications | 632 participants |
| Complications Had no Complications | 452 participants |
| Emotional Stress Had no Stress | 955 participants |
| Emotional Stress Had Stress | 129 participants |
| Helicobacter pylori Infection Negative | 199 participants |
| Helicobacter pylori Infection Positive | 434 participants |
| Helicobacter pylori Infection Unknown | 451 participants |
| Medical History Did not Have Medical History | 510 participants |
| Medical History Have Medical History | 574 participants |
| Predisposition to Hypersensitivity No | 1042 participants |
| Predisposition to Hypersensitivity Unknown | 3 participants |
| Predisposition to Hypersensitivity Yes | 39 participants |
| Pregnancy Status Not Pregnant | 349 participants |
| Pregnancy Status Pregnant | 0 participants |
| Pregnancy Status Unknown | 1 participants |
| Prior Consumption of Drugs Affecting Coagulation System No | 758 participants |
| Prior Consumption of Drugs Affecting Coagulation System Unknown | 1 participants |
| Prior Consumption of Drugs Affecting Coagulation System Yes | 325 participants |
| Sex: Female, Male Female | 350 Participants |
| Sex: Female, Male Male | 734 Participants |
| Smoking Status Non-Smoker | 599 participants |
| Smoking Status Smoker | 317 participants |
| Smoking Status Unknown | 168 participants |
| Target Diseases Acute Gastric Mucosal Lesion | 60 participants |
| Target Diseases Acute Stress-Induced Ulcer | 8 participants |
| Target Diseases Duodenal Ulcer | 221 participants |
| Target Diseases Gastric Ulcer | 768 participants |
| Target Diseases Gastroduodenal Ulcer | 23 participants |
| Target Diseases Not Provided | 4 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 1,084 |
| serious Total, serious adverse events | 9 / 1,084 |
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 | 35 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.
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 Serious Adverse Drug Reactions | 9 participants |
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.
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 Who Experienced Rebleeding After Confirmed Hemostatic Effect | 1.2 percentage of participants |
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.
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 Who Experienced Rebleeding After Observed Hemostatic Effect | 1.1 percentage of 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 | 91.6 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 8 after the last dose of study drug (Week 17)
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 | 7.1 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 | 90.3 percentage of participants |
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.
Time frame: Week 8 after the last dose of study drug (Week 17)
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 Who Experienced Rebleeding After the Completion of Treatment | 5.8 percentage of participants |