Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Lansoprazole
Lansoprazole 30 mg injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
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:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Takeda
Investigators
- Study Chair: Postmarketing Group Manager, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 254-012
- JapicCTI-142542
- JapicCTI-R160830
Study Results
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 Detail | 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). |
| Arm/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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 . |
| Period Title: Overall Study | |
| STARTED | 63 |
| COMPLETED | 58 |
| NOT COMPLETED | 5 |
Baseline Characteristics
| Arm/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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 . |
| Overall Participants | 58 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
63.5
(16.41)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
22
37.9%
|
| Male |
36
62.1%
|
| Pregnancy Status (participants) [Number] | |
| Not pregnant |
22
37.9%
|
| Pregnant |
0
0%
|
| Target Disease (participants) [Number] | |
| Acute Stress-Induced Ulcer |
46
79.3%
|
| Acute Gastric Mucosal Lesion |
12
20.7%
|
| Healthcare Category (participants) [Number] | |
| Number [participants] |
58
100%
|
| Predisposition to Hypersensitivity (participants) [Number] | |
| No |
54
93.1%
|
| Yes |
4
6.9%
|
| Helicobacter Pylori Infection (participants) [Number] | |
| Positive |
20
34.5%
|
| Negative |
16
27.6%
|
| Unknown |
22
37.9%
|
| Alcohol consumption (participants) [Number] | |
| Alcohol Consumer |
15
25.9%
|
| Alcohol Non-Consumer |
38
65.5%
|
| Unknown |
5
8.6%
|
| Smoking (participants) [Number] | |
| Smoker |
14
24.1%
|
| Non-Smoker |
40
69%
|
| Unknown |
4
6.9%
|
| Medical History (participants) [Number] | |
| Had medical history |
30
51.7%
|
| Did not have medical history |
28
48.3%
|
| Breakdown of Medical History (participants) [Number] | |
| Peptic ulcer |
13
22.4%
|
| Upper gastrointestinal bleeding |
1
1.7%
|
| Cerebrovascular accident |
4
6.9%
|
| Malignant tumor |
3
5.2%
|
| Hepatic dysfunction |
3
5.2%
|
| Renal dysfunction |
0
0%
|
| Diabetes mellitus |
2
3.4%
|
| Cardiac disorders |
2
3.4%
|
| Hypertension |
0
0%
|
| Other |
11
19%
|
| Medical Complications (participants) [Number] | |
| Had Complications |
28
48.3%
|
| Had no Complications |
30
51.7%
|
| Breakdown of Complications (participants) [Number] | |
| Hypertension |
8
13.8%
|
| Cardiac disorders |
4
6.9%
|
| Diabetes mellitus |
5
8.6%
|
| Hepatic dysfunction |
3
5.2%
|
| Anemia |
4
6.9%
|
| Malignant tumor |
2
3.4%
|
| Cerebrovascular accident |
1
1.7%
|
| Renal dysfunction |
1
1.7%
|
| Other |
18
31%
|
| Emotional Stress (participants) [Number] | |
| Had Stress |
29
50%
|
| Had no Stress |
29
50%
|
| Breakdown of Drugs (participants) [Number] | |
| Non Steroidal Anti-Inflammatory Drugs |
7
12.1%
|
| Platelet aggregation inhibitors |
5
8.6%
|
| Anticoagulants |
3
5.2%
|
| Steroids |
0
0%
|
| Other |
1
1.7%
|
| Prior Consumption of Drugs Affecting Coagulation System (participants) [Number] | |
| Had consumption |
12
20.7%
|
| Had no consumption |
46
79.3%
|
Outcome Measures
| Title | Number of Participants Reporting One or More Adverse Drug Reactions |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set was defined as all participants who were enrolled and completed the study. |
| Arm/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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 . |
| Measure Participants | 58 |
| Number [participants] |
0
0%
|
| Title | Percentage of Participants With Observed Hemostatic Effect |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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 . |
| Measure Participants | 58 |
| Number [percentage of participants] |
96.6
166.6%
|
| Title | Percentage of Participants With Confirmed Hemostatic Effect |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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 . |
| Measure Participants | 45 |
| Number [percentage of participants] |
95.6
164.8%
|
| Title | Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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 . |
| Measure Participants | 43 |
| Number [percentage of participants] |
0
0%
|
| Title | Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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 . |
| Measure Participants | 30 |
| Number [percentage of participants] |
0
0%
|
Adverse Events
| Time Frame | Baseline up to Week 17 | |
|---|---|---|
| Adverse Event Reporting Description | 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. | |
| Arm/Group Title | Lansoprazole | |
| Arm/Group Description | 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 . | |
All Cause Mortality |
||
| Lansoprazole | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Lansoprazole | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/58 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Lansoprazole | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/58 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
- 254-012
- JapicCTI-142542
- JapicCTI-R160830