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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008172
Receipt No. R000009585
Scientific Title Eicosapentaenoic acid (EPA) for colorectal aberrant crypt foci (ACF): A double-blind randomized controlled trial
Date of disclosure of the study information 2012/06/15
Last modified on 2013/09/30

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Basic information
Public title Eicosapentaenoic acid (EPA) for colorectal aberrant crypt foci (ACF): A double-blind randomized controlled trial
Acronym EPA for colorectal ACF
Scientific Title Eicosapentaenoic acid (EPA) for colorectal aberrant crypt foci (ACF): A double-blind randomized controlled trial
Scientific Title:Acronym EPA for colorectal ACF
Region
Japan

Condition
Condition Patients with both colorectal ACF and resectable polyps
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the chemopreventive effect of EPA against the colorectal ACF
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Change of the number of colorectal ACF after 1-months's intervention
Key secondary outcomes 1.The drug safety
2.Mucosal fatty acid analysis
3.The cell-proliferative and apoptotic activities in the rectal epithelium and polyps
4.Laboratory data (HDL-cholesterol, LDL-cholesterol, triglycerides, fatty acid fractions, fasting blood glucose, fasting blood insulin, HbA1c, blood urea nitrogen (BUN), creatinine)
5.physical examination findings (body weight, body mass index (BMI))

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 receive oral EPA capsule thrice 900 mg, total 2.7g per day for 1 month
Interventions/Control_2 receive oral placebo capsule thrice per day for 1 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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with both colorectal ACF and resectable polyps.
2.Willingness to provide written informed consent
Key exclusion criteria 1.History of regular use of omega-3 PUFA supplements.
2.History of regular use (defined as at least once per week) of NSAIDs and/or aspirin.
3.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
4.History of familial adenomatous polyposis
5.History of hereditary non-polyposis colorectal cancer
6.History of inflammatory bowel disease
7.Pregnancy or possibility of pregnancy
8.Patients judged as inappropriate candidates for the trial by the investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Higurashi
Organization Yokohama City Univesity
Division name Division of Gastroenterolgy
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama City
TEL 045-787-2640
Email takuma_h@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Higurashi
Organization Yokohama City Univesity
Division name Division of Gastroenterolgy
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama City
TEL 045-787-2640
Homepage URL
Email takuma_h@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City Univesity
Institute
Department

Funding Source
Organization A Grant-in-Aid for research on the Third-Term Comprehensive Control Research for Cancer and (WAKATE-B) from the Ministry of Health, Labour and Welfare, 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 横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 15 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
2012 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2013 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 14 Day
Last modified on
2013 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009585

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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