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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008311
Receipt No. 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

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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
Email

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
Email katu-you@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009788

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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