UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006344 |
|---|---|
| Receipt number | R000007526 |
| Scientific Title | Evaluation of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving oral anticoagulant dabigatran |
| Date of disclosure of the study information | 2011/09/14 |
| Last modified on | 2011/09/14 14:30:15 |
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Basic information
Public title
Evaluation of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving oral anticoagulant dabigatran
Acronym
Evaluation of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving oral anticoagulant dabigatran
Scientific Title
Evaluation of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving oral anticoagulant dabigatran
Scientific Title:Acronym
Evaluation of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving oral anticoagulant dabigatran
Region
| Japan |
Condition
Condition
Upper gastrointestinal mucosal injury
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving dabigatran by using a questionnaire and endoscopic examination. In patients with gastrointestinal mucosal injuries confirmed by endoscopy, various antiulcer agents were administered and their efficacy was investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The incidence of upper endoscopic findings(redness, petechia, erosion, and ulcer) after administration of dabigatran for 4 weeks
Key secondary outcomes
a. Evaluation of abdominal symptoms
b. The effect of various antiulcer agents in patients with dabigatran-induced gastrointestinal mucosal injuries
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dabigatran 300mg/day + Rabeprazole 10mg/day for 4 weeks
Interventions/Control_2
Dabigatran 300mg/day + Famotidine 20mg/day for 4 weeks
Interventions/Control_3
Dabigatran 300mg/day + Rebamipide 300mg/day for 4 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Patients 20 years or older, without distinction of sex
b. Patients who receive dabigatran for non-valvular atrial fibrillation
c. Written informed consent is required from all participants
Key exclusion criteria
a. Patients with severe renal failure including those on hemodialysis (creatinine clearance of less than 30mL/min)
b. Patients having organic lesions with a risk of bleeding (within 6 months after the onset of hemorrhagic stroke)
c. Patients with a spinal/epidural catheter inserted or those in which the spinal/epidural catheter was just removed within 1 hour
d. Patients with a history of hypersensitivity for tabeprazole, famotidine, or rebamipide
e. Patients who are taking itraconazole
f. Patients judged by investigators as ineligible for study enrollment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Hamaguchi |
Organization
Kobe University Hospital
Division name
Department of neurology
Zip code
Address
7-5-2,Kusunoki-cho,Chuo-ku,Kobe-city
TEL
078-382-5885
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Hamaguchi |
Organization
Kobe University Hospital
Division name
Department of neurology
Zip code
Address
7-5-2,Kusunoki-cho,Chuo-ku,Kobe-city
TEL
078-382-5885
Homepage URL
hamah@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2011 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 14 | Day |
Last modified on
| 2011 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007526
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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