♦Basic information
JapicCTI-No. JapicCTI-142542
♦Title of the study
Title of the study Takepron Intravenous 30 mg specified drug-use survey [Acute stress ulcer and acute gastric mucosal lesions]
Public title of the study
Primary sponsor TAKEDA PHARMACEUTICAL COMPANY LTD.
Secondary sponsor  
Study Type non-interventional
Summary This specified drug-use 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 for (Takepron Intravenous 30 mg) to a large number of patients 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% 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.
♦Details of the study
Disease or condition Acute stress ulcer and acute gastric mucosal lesions
Intervention
Intervention name Takepron Intravenous 30 mg (lansoprazole)
Classification name(code) of the intervention 232 (agents for peptic ulcer)
Dosage And administration of the intervention 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.
Control intervention name  
Classification name(code) of the control intervention  
Dosage And administration of the control intervention  
Objectives of the study 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 Takepron Intravenous 30 mg to a large number of patients with acute stress ulcer or acute gastric mucosal lesion in daily medical practice
Study phase Other
Study design Postmarketing surveillance
Target sample size 100
Inclusion Criteria Patients 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).



SexF     Both
Exclusion Criteria

Outcome
Primary Outcome Frequency of adverse events (adverse drug reactions)
Primary timeframe: Up to 9 weeks
Timepoints The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with lansoprazole are defined as adverse drug reactions.
Secondary Outcome 1. Hemostatic effect
2. Rebleeding rate during treatment with Takepron 30 mg Injection
3. Rebleeding rate after the completion of treatment with Takepron 30 mg Injection
Secondary timeframe: Up to 9 weeks from baseline
Timepoints 1. In patients for whom hemostasis is confirmed by endoscopy, the frequencies of hemostatic effects of Takepron 30 mg Injection are tabulated by the degree of improvement (i.e., "markedly improved," "moderately improved," "slightly improved," and "poor").
2. In patients for whom hemostasis is confirmed by endoscopy performed after the start of treatment with Takepron 30 mg Injection, the rebleeding rates during the period starting from baseline until the completion of treatment with Takepron 30 mg Injection are tabulated.
3. In patients for whom hemostasis is confirmed by endoscopy, the rebleeding rates at 8 weeks after the completion of treatment with Takepron 30 mg Injection are tabulated.
Institutions Approximately 50-80 centers
Duration of the study 2007-1-29  `  2010-3-31
Study status Study completed
recruitment status Study Completed
Region Japan
♦Secondary ID
Related ID Name Clinicaltrials.gov Registry ID
Related ID number NCT02170207
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization Takeda Pharmaceutical Company Limited
Division Contact for Clinical Trial Information
Contact person or e-mail address etc. https://www.takeda.co.jp/contact/form/jp/form/
Organization@(Scientific) Takeda Pharmaceutical Company Limited
Division@(Scientific) Post Marketing Surveillance, Pharmacovigilance Department, Pharmaceutical Development Division
Contact person or e-mail address etc.@(Scientific) https://www.takeda.co.jp/contact/form/jp/form/
♦Other
Source funded
Name of research funds
Other
♦History
History
2014/7/2   revised
2014/6/3   revised
2014/5/22   application date