UMIN-CTR Clinical Trial

Basic information
Public title	Study on injury for the small intestinal mucosa with the antithrombotic drug therapy after the percutaneous transluminal coronary angioplasty
Acronym	Study on injury for the small intestinal mucosa with the antithrombotic drug therapy
Scientific Title	Study on injury for the small intestinal mucosa with the antithrombotic drug therapy after the percutaneous transluminal coronary angioplasty
Scientific Title:Acronym	Study on injury for the small intestinal mucosa with the antithrombotic drug therapy
Region	Japan

Condition
Condition	Small intestinal mucosal injury
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploratory study for the small intestinal mucosal injury by the low-dose aspirin
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of the small intestinal injuries induced by chemothelapy
Key secondary outcomes	1.Location and From of small intestinal injuries. 2.We compare the change of Plasma diamioxidase(DAO) activities and calprotectin before and after chemotherapy. 3.We check a correlation with Lewis score in DAO and calprotectin

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients that word of mouth and written informed consent were obtained. The patients who take low-dose aspirin continuously.
Key exclusion criteria	1.The patient who cannot swallow it 2.The patient whom the state of the body has bad. 3.The patient who has a pacemaker and other medical equipment in the body. 4.The patient that an agreement of treating it surgically is not provided when a capsule endoscope stayed. 5.The patient who participates in study influencing this study directly or indirectly. 6.The patient who judged that we were inappropriate.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazuhide Higuchi
Organization	Osaka Medical College
Division name	Second Depertment of Internal Medicine
Zip code
Address	2-7,Daigakumachi,Takatuki-city,Osaka,Japan
TEL	072-683-1221
Email	higuchi@poh.osaka-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Toshihisa Takeuchi
Organization	Osaka Medical College
Division name	Second Dep of Internal Medicine
Zip code
Address	2-7,Daigakumachi,Takatuki-city,Osaka,Japan
TEL	072-727-1824
Homepage URL
Email	in2097@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
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	2014 Year 08 Month 13 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	Completed
Date of protocol fixation	2014 Year 06 Month 06 Day
Date of IRB	2014 Year 08 Month 03 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2016 Year 06 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We tell subjects about the results of the capsule endoscope.

Management information
Registered date	2014 Year 08 Month 13 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017122