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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000100
Receipt No. 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

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Basic information
Public title Randomized double blind trial for inhibitory effect of sulindac and etodorac on aberrant crypt foci (ACF)
Acronym Randomized double blind trial for inhibitory effect of sulindac and etodorac on ACF
Scientific Title Randomized double blind trial for inhibitory effect of sulindac and etodorac on aberrant crypt foci (ACF)
Scientific Title:Acronym Randomized double blind trial for inhibitory effect of sulindac and etodorac on ACF
Region
Japan

Condition
Condition Subjects with aberrant crypt foci(ACF)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Observation of ACF and polyp using magnifying endoscopy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Oral administration of sulindac 150mg twice daily for 8 weeks
Interventions/Control_2 Oral administration of etodorac 200mg twice daily for 8 weeks
Interventions/Control_3 Oral administration of lactose 200mg twice daily for 8 weeks
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion 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
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiro Niitsu
Organization Sapporo Medical University School of Medicine
Division name 4th Department of Internal Medicine
Zip code
Address Chuo-ku, South-1, West-16, Sapporo 060-8543, Japan
TEL 011-611-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Takayama
Organization Sapporo Medical University School of Medicine
Division name 4th Department of Internal Medicine
Zip code
Address Chuo-ku, South-1, West-16, Sapporo 060-8543, Japan
TEL 011-611-2111(3254)
Homepage URL
Email

Sponsor
Institute 4th Department of Internal Medicine, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Grant from Ministry of Education, Science, Sports and Culture in Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 10 Day

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
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2001 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2002 Year 02 Month 01 Day
Last follow-up date
2007 Year 10 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 31 Day
Last modified on
2009 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.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


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