Unique ID issued by UMIN | C000000100 |
---|---|
Receipt number | R000000127 |
Scientific Title | Randomized double blind trial for inhibitory effect of sulindac and etodorac on aberrant crypt foci (ACF) |
Date of disclosure of the study information | 2005/09/10 |
Last modified on | 2009/03/22 23:57:17 |
Randomized double blind trial for inhibitory effect of sulindac and etodorac on aberrant crypt foci (ACF)
Randomized double blind trial for inhibitory effect of sulindac and etodorac on ACF
Randomized double blind trial for inhibitory effect of sulindac and etodorac on aberrant crypt foci (ACF)
Randomized double blind trial for inhibitory effect of sulindac and etodorac on ACF
Japan |
Subjects with aberrant crypt foci(ACF)
Gastroenterology |
Others
NO
This study aims to examine if sulindac or etodorac, a selective COX-2 inhibitor, can erradicate pre-existing ACF and inhibit formation of colorectal polyps.
Efficacy
Exploratory
Explanatory
Not applicable
Observation of ACF and polyp using magnifying endoscopy
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
3
Prevention
Medicine |
Oral administration of sulindac 150mg twice daily for 8 weeks
Oral administration of etodorac 200mg twice daily for 8 weeks
Oral administration of lactose 200mg twice daily for 8 weeks
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)Obtaining informed consent 2)Positive for ACF 3)Negative for polyps (including polypectomized colon) 4)WBC more than 4000/mm3 5)Platlet more than 100,000/mm3 6)BUN less than 25 mg/dl 7)GOT and GPT within 2.5-fold normal limit 8)Total bilirubin less than 2.0mg/dl
1)Intake of NSAIDs for more than 1 week within the last 2 months 2)pregnant 3)Posibility of becoming pregnant in the study period 4)Active gastrointestinal ulcer 5)Cancer (except for complete cure) 6)Active infection 7)Allergy for sulindac or etodorac
360
1st name | |
Middle name | |
Last name | Yoshiro Niitsu |
Sapporo Medical University School of Medicine
4th Department of Internal Medicine
Chuo-ku, South-1, West-16, Sapporo 060-8543, Japan
011-611-2111
1st name | |
Middle name | |
Last name | Tetsuji Takayama |
Sapporo Medical University School of Medicine
4th Department of Internal Medicine
Chuo-ku, South-1, West-16, Sapporo 060-8543, Japan
011-611-2111(3254)
4th Department of Internal Medicine, Sapporo Medical University School of Medicine
Grant from Ministry of Education, Science, Sports and Culture in Japan
NO
2005 | Year | 09 | Month | 10 | Day |
Unpublished
Completed
2001 | Year | 08 | Month | 17 | Day |
2002 | Year | 02 | Month | 01 | Day |
2007 | Year | 10 | Month | 01 | Day |
2008 | Year | 03 | Month | 01 | Day |
2008 | Year | 03 | Month | 01 | Day |
2008 | Year | 05 | Month | 01 | Day |
2005 | Year | 08 | Month | 31 | Day |
2009 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000127
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |