UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008311 |
|---|---|
| Receipt number | R000009788 |
| Scientific Title | Clinical investigation of upper gastrointestinal mucosal injury in patients receiving antiplatelet agents as a single agent or in combination: A randomaized control study in healthy volunteers. |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2013/01/05 09:42:29 |
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Basic information
Public title
Clinical investigation of upper gastrointestinal mucosal injury in patients receiving antiplatelet agents as a single agent or in combination: A randomaized control study in healthy volunteers.
Acronym
Upper gastrointestinal mucosal injury by antiplatelet agents
Scientific Title
Clinical investigation of upper gastrointestinal mucosal injury in patients receiving antiplatelet agents as a single agent or in combination: A randomaized control study in healthy volunteers.
Scientific Title:Acronym
Upper gastrointestinal mucosal injury by antiplatelet agents
Region
| Japan |
Condition
Condition
Upper gastrointestinal mucosal injury by antiplatelet agents
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of upper gastrointestinal mucosal injury in healthy volunteers receiving low-dose aspirin and clopidogrel, either alone or in combination using upper gastrointestinal endoscopy
Basic objectives2
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)
Key secondary outcomes
Symptom assessment (using GSRS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
aspirin (enteric tablet) 100mg/day+ placebo for 2 weeks
Interventions/Control_2
aspirin (enteric tablet) 100mg/day+ rebamipide 300mg/day for 2 weeks
Interventions/Control_3
aspirin (enteric tablet) 100mg/day+ clopidogrel 75mg/day+ placebo for 2 weeks
Interventions/Control_4
aspirin (enteric tablet) 100mg/day+ clopidogrel 75mg/day+rebamipide 300mg/day for 2 weeks
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
a. Healthy subjects who have a normal physical examination and laboratory results
b.Previous history of peptic ulcer
c.Sufficient informed consent is obtained
Key exclusion criteria
a. Presence of diseases with a bleeding tendency
b. Previous hypersensitivity for ingredient of aspirin
c.Severe comorbidities (including malignant tumor, liver cirrhosis, renal failure, and cardiac failure)
d. With no regular use of medicine
e.Individuals judged by investigators as ineligible for study enrollment.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto |
Organization
Hyogo College of Medicine
Division name
Department of lower digestive organs
Zip code
Address
1-1 Mukugawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6662
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Tozawa |
Organization
Hyogo College of Medicine
Division name
Department of lower digestive organs
Zip code
Address
1-1 Mukugawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6662
Homepage URL
katu-you@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
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
尼崎中央病院/Amagasaki Chuou Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 30 | Day |
Last modified on
| 2013 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009788
