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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001551
Receipt No. R000001872
Scientific Title Analysis for effect of Eicosapentaenoic acid (EPA) on aberrant crypt foci (ACF)
Date of disclosure of the study information 2009/02/01
Last modified on 2008/12/08

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Basic information
Public title Analysis for effect of Eicosapentaenoic acid (EPA) on aberrant crypt foci (ACF)
Acronym Analysis for effect of EPA on ACF
Scientific Title Analysis for effect of Eicosapentaenoic acid (EPA) on aberrant crypt foci (ACF)
Scientific Title:Acronym Analysis for effect of EPA on ACF
Region
Japan

Condition
Condition Subjects with aberrant crypt foci (ACF)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Omega-3 polyunsaturated fatty acids EPA exert a protective effect on the development of colorectal cancer in animal models and cancer cell lines. EPA is marketed as a dietary supplement, and it is authorized as a medicine for hyperlipidemia in Japan. The aim of this study is to examine the effect of EPA on ACF and polyps and to validate the possibility of chemoprevention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Observation of ACF and polyps using magnifying endoscopy
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 NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Oral administration of EPA 600mg three times daily for one month.
Interventions/Control_2 No administration of newly drug for one month.
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 a. Obtaining informed consent
b. Positive for ACF
Key exclusion criteria a. Liver cirrhosis or chronic hepatic, chronic renal failure
b. Women who are pregnant or with a possibility of pregnancy
c. Alcohol dependence or drug dependence
d. Drug allergy
e. Heart failure
f. Hemorrhagic
g. Those who have started to use other medication or dietary supplement in study period
h. The patient that it is already taken EPA
i. History of colorectal cancer
j. Family history of colorectal cancer
k. The patient currently taking NSAIDs
l. Inadequate to entry to this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Takahashi
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
Homepage URL
Email

Sponsor
Institute Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant from Ministry of Education, Science, Sports and Culture in Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2009 Year 02 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 Preinitiation
Date of protocol fixation
2008 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 04 Day
Last modified on
2008 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001872

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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