UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028259 |
|---|---|
| Receipt number | R000032336 |
| Scientific Title | The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial |
| Date of disclosure of the study information | 2017/07/18 |
| Last modified on | 2023/07/22 22:40:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial
Acronym
The efficacy of aspirin and metformin for rectal ACF
Scientific Title
The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial
Scientific Title:Acronym
The efficacy of aspirin and metformin for rectal 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 additional metfromin to aspirin against the rectal ACF
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
The amount of change rectal ACF in aspirin plus placebo group and aspirin plus metformin group after 8weeks intervention
Key secondary outcomes
The number of rectal ACF before and after intervention in both group
Ki67 labeling index of colorectal adnoema/cancer and normal mucosa before and after intervention
Safety
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
receive 100mg aspirin and placebo for 8 weeks
Interventions/Control_2
receive 100mg aspirin and 250mg metformin for 8 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with resectable polyps.
2.Patients with more than 10 rectal ACF
3.Willingness to provide written informed consent
Key exclusion criteria
1.Patients with lesion which preferred early resection.
2.History of regular use (defined as at least once per week) of NSAIDs and/or aspirin.
3.History of regular use of warfarin and/or DOAC.
4.History of diabetes mellitus (defined as more than HbA1c 6.5% or regular use of anti-diabetic drugs) .
5.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
6.History of familial adenomatous polyposis,
hereditary non-polyposis colorectal cancer and inflammatory bowel disease
7.Pregnancy or possibility of pregnancy
8.Contraindication to aspirin or metformin
9.Allergy to aspirin or metformin
10.Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Higurashi |
| Middle name | |
| Last name | Takuma |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Higurashi |
| Middle name | |
| Last name | Takuma |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital IRB
Address
3-9 Fukuura Kanazawa-ku Yokohama City
Tel
045-787-2640
rinri@yokohama-cu.ac.jp
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（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032336
