UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006254
Receipt number R000006724
Scientific Title Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial
Date of disclosure of the study information 2011/09/01
Last modified on 2016/06/28 21:40:35

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Basic information

Public title

Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial

Acronym

Metformin efficacy and safety for colorectal polyps

Scientific Title

Metformin efficacy and safety for colorectal polyps: A double blind randomized controlled trial

Scientific Title:Acronym

Metformin efficacy and safety for colorectal polyps

Region

Japan


Condition

Condition

Subjects after resection of colorectal polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the chemopreventive effects and drug safety of metformin against metachronous colorectal polyps in nondiabetic post-polypectomy patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

The prevalence of colorectal polyps and number of polyps after 1-year intervention.

Key secondary outcomes

drug safety
body weight, body mass index (BMI)
laboratory data (fasting blood glucose, fasting blood insulin, HbA1c, total cholesterol, LDL-cholesterol, blood urea nitrogen (BUN), serum creatinine)
cell proliferative and apoptotic activities in colorectal epithelium and polyps
Expression levels of protein (AMPK, mTOR/S6K) of colorectal epithelium and polyps


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

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Oral administration of metformin 250mg once daily for one year.

Interventions/Control_2

Oral administration of placebo tablet (lactose 250mg) once daily for one year.

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) There is no colorectal polyps after polypectomy.
2) Written informed consent was obtained.

Key exclusion criteria

1) History of diabetes mellitus (use of medication and/or over HbA1c 6.5%)
2) History of regular NSAIDs and/or aspirin medication (defined as at least once per week)
3) History of bowel surgery
4) History of malignant disease (excluded carcinoma in adenoma, carcinoma in situ already had been resected)
5) History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure.
6) History of familial adenomatous polyposis
7) History of hereditary non-polyposis colorectal cancer
8) Histroy of inflammatory bowel disease
9) Women who are pregnant or with a possibility of pregnancy
10) Patients judged inappropriate for the trial by investigators

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Nakajima

Organization

Yokohama City University School of Medicine, Yokohama, Japan

Division name

Division of Gastroenterology

Zip code


Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2640

Email

nakajima-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuma Higurashi

Organization

Yokohama City University School of Medicine, Yokohama, Japan

Division name

Division of Gastroenterology

Zip code


Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2640

Homepage URL


Email

takuma_h@yokohama-cu.ac.jp


Sponsor or person

Institute

Division of Gastroenterology, Yokohama City University School of Medicine, Yokohama, Japan

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Chigasaki Municipal Hospital, Kanagawa.
Tokyo Metropolitan Hiroo Hospital, Tokyo.
Yokohama Rosai Hospital, Kanagawa.
Hiratsuka City Hospital, Kanagawa.
Kanto Medical Center, NTT East, Tokyo.

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

茅ケ崎市立病院(神奈川県)
都立広尾病院(東京都)
横浜労災病院(神奈川県)
平塚市民病院(神奈川県)
NTT東日本関東病院(東京都)
小田原市立病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 01 Day


Related information

URL releasing protocol

http://bmccancer.biomedcentral.com/articles/10.1186/1471-2407-12-118

Publication of results

Published


Result

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S1470204515005653

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

Main results already published

Date of protocol fixation

2011 Year 07 Month 07 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2014 Year 12 Month 30 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 05 Month 31 Day

Date analysis concluded

2015 Year 07 Month 30 Day


Other

Other related information



Management information

Registered date

2011 Year 08 Month 30 Day

Last modified on

2016 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006724


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name