UMIN ID: C000000100
Registered date:10/09/2005
Randomized double blind trial for inhibitory effect of sulindac and etodorac on aberrant crypt foci (ACF)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Subjects with aberrant crypt foci(ACF) |
| Date of first enrollment | 2002/02/01 |
| Target sample size | 360 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 |
Outcome(s)
| Primary Outcome | Observation of ACF and polyp using magnifying endoscopy |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 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 |
Related Information
| Primary Sponsor | 4th Department of Internal Medicine, Sapporo Medical University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant from Ministry of Education, Science, Sports and Culture in Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tetsuji Takayama |
| Address | Chuo-ku, South-1, West-16, Sapporo 060-8543, Japan Japan |
| Telephone | 011-611-2111(3254) |
| Affiliation | Sapporo Medical University School of Medicine 4th Department of Internal Medicine |
| scientific contact | |
| Name | Yoshiro Niitsu |
| Address | Chuo-ku, South-1, West-16, Sapporo 060-8543, Japan Japan |
| Telephone | 011-611-2111 |
| Affiliation | Sapporo Medical University School of Medicine 4th Department of Internal Medicine |