Trial Outcomes & Findings for Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions] (NCT NCT02170207)
NCT ID: NCT02170207
Last Updated: 2016-03-08
Results Overview
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.
COMPLETED
63 participants
Baseline up to Week 9
2016-03-08
Participant Flow
Participants took part in the study at 14 investigative site in Japan from 29 January 2007 to 31 March 2010.
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).
Participant milestones
| Measure |
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 .
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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 .
|
|---|---|
|
Overall Study
Case report forms unavailable
|
5
|
Baseline Characteristics
Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]
Baseline characteristics by cohort
| Measure |
Lansoprazole
n=58 Participants
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 .
|
|---|---|
|
Target Disease
Acute Stress-Induced Ulcer
|
46 participants
n=5 Participants
|
|
Target Disease
Acute Gastric Mucosal Lesion
|
12 participants
n=5 Participants
|
|
Healthcare Category
|
58 participants
n=5 Participants
|
|
Predisposition to Hypersensitivity
No
|
54 participants
n=5 Participants
|
|
Predisposition to Hypersensitivity
Yes
|
4 participants
n=5 Participants
|
|
Helicobacter Pylori Infection
Positive
|
20 participants
n=5 Participants
|
|
Helicobacter Pylori Infection
Negative
|
16 participants
n=5 Participants
|
|
Helicobacter Pylori Infection
Unknown
|
22 participants
n=5 Participants
|
|
Alcohol consumption
Alcohol Consumer
|
15 participants
n=5 Participants
|
|
Alcohol consumption
Alcohol Non-Consumer
|
38 participants
n=5 Participants
|
|
Alcohol consumption
Unknown
|
5 participants
n=5 Participants
|
|
Smoking
Smoker
|
14 participants
n=5 Participants
|
|
Smoking
Non-Smoker
|
40 participants
n=5 Participants
|
|
Smoking
Unknown
|
4 participants
n=5 Participants
|
|
Medical History
Had medical history
|
30 participants
n=5 Participants
|
|
Medical History
Did not have medical history
|
28 participants
n=5 Participants
|
|
Breakdown of Medical History
Peptic ulcer
|
13 participants
n=5 Participants
|
|
Breakdown of Complications
Cerebrovascular accident
|
1 participants
n=5 Participants
|
|
Breakdown of Complications
Renal dysfunction
|
1 participants
n=5 Participants
|
|
Breakdown of Complications
Other
|
18 participants
n=5 Participants
|
|
Emotional Stress
Had Stress
|
29 participants
n=5 Participants
|
|
Emotional Stress
Had no Stress
|
29 participants
n=5 Participants
|
|
Breakdown of Drugs
Non Steroidal Anti-Inflammatory Drugs
|
7 participants
n=5 Participants
|
|
Breakdown of Drugs
Platelet aggregation inhibitors
|
5 participants
n=5 Participants
|
|
Breakdown of Drugs
Anticoagulants
|
3 participants
n=5 Participants
|
|
Breakdown of Drugs
Steroids
|
0 participants
n=5 Participants
|
|
Breakdown of Drugs
Other
|
1 participants
n=5 Participants
|
|
Prior Consumption of Drugs Affecting Coagulation System
Had consumption
|
12 participants
n=5 Participants
|
|
Prior Consumption of Drugs Affecting Coagulation System
Had no consumption
|
46 participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 16.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Pregnancy Status
Not pregnant
|
22 participants
n=5 Participants
|
|
Pregnancy Status
Pregnant
|
0 participants
n=5 Participants
|
|
Breakdown of Medical History
Upper gastrointestinal bleeding
|
1 participants
n=5 Participants
|
|
Breakdown of Medical History
Cerebrovascular accident
|
4 participants
n=5 Participants
|
|
Breakdown of Medical History
Malignant tumor
|
3 participants
n=5 Participants
|
|
Breakdown of Medical History
Hepatic dysfunction
|
3 participants
n=5 Participants
|
|
Breakdown of Medical History
Renal dysfunction
|
0 participants
n=5 Participants
|
|
Breakdown of Medical History
Diabetes mellitus
|
2 participants
n=5 Participants
|
|
Breakdown of Medical History
Cardiac disorders
|
2 participants
n=5 Participants
|
|
Breakdown of Medical History
Hypertension
|
0 participants
n=5 Participants
|
|
Breakdown of Medical History
Other
|
11 participants
n=5 Participants
|
|
Medical Complications
Had Complications
|
28 participants
n=5 Participants
|
|
Medical Complications
Had no Complications
|
30 participants
n=5 Participants
|
|
Breakdown of Complications
Hypertension
|
8 participants
n=5 Participants
|
|
Breakdown of Complications
Cardiac disorders
|
4 participants
n=5 Participants
|
|
Breakdown of Complications
Diabetes mellitus
|
5 participants
n=5 Participants
|
|
Breakdown of Complications
Hepatic dysfunction
|
3 participants
n=5 Participants
|
|
Breakdown of Complications
Anemia
|
4 participants
n=5 Participants
|
|
Breakdown of Complications
Malignant tumor
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 9Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
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.
Outcome measures
| Measure |
Lansoprazole
n=58 Participants
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 .
|
|---|---|
|
Number of Participants Reporting One or More Adverse Drug Reactions
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
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.
Outcome measures
| Measure |
Lansoprazole
n=58 Participants
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 .
|
|---|---|
|
Percentage of Participants With Observed Hemostatic Effect
|
96.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
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.
Outcome measures
| Measure |
Lansoprazole
n=45 Participants
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 .
|
|---|---|
|
Percentage of Participants With Confirmed Hemostatic Effect
|
95.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
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.
Outcome measures
| Measure |
Lansoprazole
n=43 Participants
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 .
|
|---|---|
|
Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Lansoprazole
n=30 Participants
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 .
|
|---|---|
|
Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
|
0 percentage of participants
|
Adverse Events
Lansoprazole
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER