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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006344
Receipt No. 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

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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
Email

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
Email hamah@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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