Unique ID issued by UMIN | UMIN000029926 |
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Receipt number | R000034146 |
Scientific Title | The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial |
Date of disclosure of the study information | 2017/11/13 |
Last modified on | 2022/11/14 22:18:11 |
The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial
The efficacy of LTRA for human ACF
The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial
The efficacy of LTRA for human ACF
Japan |
Patients with both colorectal ACF and resectable polyps
Gastroenterology |
Others
NO
To evaluate the chemopreventive effect of LTRA against the rectal ACF
Safety,Efficacy
Exploratory
Pragmatic
Phase II
The amount of change rectal ACF in LTRA group and control group after 8weeks intervention
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
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
receive Montelukast 10mg for 8 weeks
no treatment observation
30 | years-old | <= |
80 | years-old | > |
Male and Female
1.Patients with resectable polyps.
2.Patients with more than 5 rectal ACF
3.Willingness to provide written informed consent
1.Patients with lesion which preferred early resection.
2.History of use of LTRA within 2months before trial entry.
3.History of malignant disease within 5 yeears before trial entry.
4.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
5.History of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer and inflammatory bowel disease
6.Pregnancy or possibility of pregnancy
7.Contraindication to Montelukast
8.Allergy to Montelukast
9.Regular use of NSAIDs, metformin, piogrlitazone
10.Patients judged as inappropriate candidates for the trial by the investigators
40
1st name | Takuma |
Middle name | |
Last name | Higurashi |
Yokohama City University
Department of Gastroenterology and Hepatology
236-0004
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
045-787-2640
takuma_h@yokohama-cu.ac.jp
1st name | Takuma |
Middle name | |
Last name | Higurashi |
Yokohama City University
Department of Gastroenterology and Hepatology
236-0004
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
045-787-2640
takuma_h@yokohama-cu.ac.jp
Yokohama City University
Kanagawa Institute of Industrial Science and Technology
Local Government
Yokohama City University Hospital IRB
3-9 Fukuura Kanazawa-ku Yokohama City
81-45-787-2640
takuma_h@yokohama-cu.ac.jp
NO
横浜市立大学附属病院
2017 | Year | 11 | Month | 13 | Day |
Published
40
LTRA decreased rectal ACF
2022 | Year | 11 | Month | 14 | Day |
2022 | Year | 06 | Month | 04 | Day |
Completed
2017 | Year | 08 | Month | 31 | Day |
2017 | Year | 05 | Month | 30 | Day |
2017 | Year | 11 | Month | 13 | Day |
2022 | Year | 03 | Month | 31 | Day |
2017 | Year | 11 | Month | 10 | Day |
2022 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034146
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