UMIN-CTR Clinical Trial

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

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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 or person

Institute

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

Institute

Department

Personal name



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

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