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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000698
Receipt No. 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

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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
Institute Basic and clinical researches on the development of chemopreventive drugs
Institute
Department

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
URL(English) https://upload.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


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