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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000028259 |
Receipt No. | 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 | 2020/01/20 |
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 |
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Condition | ||
Condition | Patients with both colorectal ACF and resectable polyps | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Yokohama City University |
Institute | |
Department |
Funding Source | |
Organization | Yokohama City University Hospital |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032336 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |