UMIN-CTR Clinical Trial

Basic information
Public title	Prevention of asprin-induced small-intestinal injury by Poraprezinc
Acronym	Prevention of asprin-induced small-intestinal injury by Poraprezinc
Scientific Title	Prevention of asprin-induced small-intestinal injury by Poraprezinc
Scientific Title:Acronym	Prevention of asprin-induced small-intestinal injury by Poraprezinc
Region	Japan

Condition
Condition	small-intestinal injury
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of Prevention for asprin-induced small-intestinal injury by Poraprezinc
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Incidence of asprin-induced small-intestinal injury (redness, erosion, ulcer) 2. Evaluation of endoscopic findings with capsule endoscopy after taking Poraprezinc or not.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	taking Poraprezinc for 4 weeks
Interventions/Control_2	follow-up without any medication
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. History of taking Asprin 2. With no antibiotic substance 3. Negative for disease germ from feces examination 4. Over 20 years old 5. Agreement of informed concent
Key exclusion criteria	1. Patients with inflammatory bowel disease 2. Patients with digestion and absorption disorder 3. Patients who is taking Poraprezinc 4. Patients who is taking other medicines for gastritis, such as Misoprostol, Rebamipide, etc. 5. Patients who is taking Penicillamine and Levothyroxine sodium 6. Patients with stenosis of gastrointestinal tract and severe adhesion 7. Pregnant and nursing women 8. Patients with severe ulcerative lesion with capsule endoscopy
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinji Tanaka
Organization	Hiroshima University Hospital
Division name	Department of Endoscopy
Zip code
Address	1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Hiroshima University Hospital
Division name	Department of Endoscopy
Zip code
Address
TEL	082-257-5537
Homepage URL
Email	oka4683@hiroshima-u.ac.jp

Sponsor
Institute	Department of Endoscopy, Hiroshima 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	2010 Year 06 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	Completed
Date of protocol fixation	2009 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2011 Year 09 Month 30 Day
Date of closure to data entry	2011 Year 09 Month 30 Day
Date trial data considered complete	2011 Year 12 Month 31 Day
Date analysis concluded	2012 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2010 Year 06 Month 01 Day
Last modified on	2013 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004466

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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