UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000698
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin

Acronym

Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin (J-FAPP Study 2)

Scientific Title

Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin

Scientific Title:Acronym

Japan Familial adenomatous polyposis prevention study:
Randomized controlled trial by low-dose aspirin (J-FAPP Study 2)

Region

Japan


Condition

Condition

Familial adenomatous polyposis

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Only a reduction in the number of rectal tumors is regarded as the event.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Aspirin (100 mg/day) enteric-coated tablet

Interventions/Control_2

Placebo tablet

Interventions/Control_3


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

16 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

# 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

Key exclusion criteria

# 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.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular-Targeting Cancer Prevention

Zip code


Address

3-1-2F Kyomachibori Nishi-ku 2-chome Osaka Japan

TEL

06-6445-5585

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hideki Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular-Targeting Cancer Prevention

Zip code


Address

3-1-2F Kyomachibori Nishi-ku 2-chome Osaka Japan

TEL

06-6445-5585

Homepage URL


Email



Sponsor or person

Institute

Basic and clinical researches on the development of chemopreventive drugs

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2007 Year 05 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

2006 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2007 Year 05 Month 01 Day

Last follow-up date

2009 Year 07 Month 01 Day

Date of closure to data entry

2009 Year 12 Month 01 Day

Date trial data considered complete

2010 Year 05 Month 01 Day

Date analysis concluded

2011 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 05 Month 01 Day

Last modified on

2013 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000835


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name