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Recruitment status Completed
Unique ID issued by UMIN UMIN000003687
Receipt No. R000004466
Scientific Title Prevention of asprin-induced small-intestinal injury by Poraprezinc
Date of disclosure of the study information 2010/06/01
Last modified on 2013/03/27

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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


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