Unique ID issued by UMIN | UMIN000000698 |
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Receipt number | R000000835 |
Scientific Title | Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin |
Date of disclosure of the study information | 2007/05/02 |
Last modified on | 2013/03/21 14:12:16 |
Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin
Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin (J-FAPP Study 2)
Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin
Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin (J-FAPP Study 2)
Japan |
Familial adenomatous polyposis
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
The objective of this study is to evaluate the colorectal cancer preventive effect of aspirin enteric coated tablet (100 mg/day per tablet) in patients with familial adenomatous polyposis in a double-blind, randomized study.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
Only a reduction in the number of rectal tumors is regarded as the event.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as a block.
Central registration
2
Prevention
Medicine |
Aspirin (100 mg/day) enteric-coated tablet
Placebo tablet
16 | years-old | <= |
70 | years-old | >= |
Male and Female
# Patients with previous or existing 100 or more colorectal adenomas, or those with detrimental APC gene
# Patients with at least 2 cm of rectal mucosa left intact
# Patients who are able to undergo colonoscopy every 6 months
# Japanese
# Patients currently taking antithrombotics such as Bayaspirin, Bufferin, Panaldine, Warfarin and Persantin
# Patients with gastric ulcer, small intestinal ulcer, anastomotic ulcer or colorectal ulcer
# Patients with a history of treatment of gastric or duodenal ulcer (those with successful eradication of Helicobacter pylori and ulcer resolution at S2 are allowed to participate in the study)
# Confirmation method
Each candidate patient should be interviewed to confirm that he or she has no medical history of gastric or duodenal ulcer and no pain in fasting state. Most recent GIF or UGI findings should be obtained as much as possible.
# Patients with bleeding tendency, a platelet count of < 100,000, or with abnormal PT
# Patients with any existing cancer at the time of participation in the study.
# Patients with known allergy to aspirin.
# Patients currently taking anticancer drugs.
# Women who are or may be pregnant during the study period.
# Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.
70
1st name | |
Middle name | |
Last name | Hideki Ishikawa |
Kyoto Prefectural University of Medicine
Department of Molecular-Targeting Cancer Prevention
3-1-2F Kyomachibori Nishi-ku 2-chome Osaka Japan
06-6445-5585
1st name | |
Middle name | |
Last name | Hideki Ishikawa |
Kyoto Prefectural University of Medicine
Department of Molecular-Targeting Cancer Prevention
3-1-2F Kyomachibori Nishi-ku 2-chome Osaka Japan
06-6445-5585
Basic and clinical researches on the development of chemopreventive drugs
Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer
Japan
NO
2007 | Year | 05 | Month | 02 | Day |
Published
Completed
2006 | Year | 08 | Month | 17 | Day |
2007 | Year | 05 | Month | 01 | Day |
2009 | Year | 07 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2007 | Year | 05 | Month | 01 | Day |
2013 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000835
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