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

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 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


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

Value
https://center6.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