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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018736
Receipt No. R000021673
Scientific Title Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine
Date of disclosure of the study information 2015/08/21
Last modified on 2019/03/27

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Basic information
Public title Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine
Acronym Japan FAP prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine (J-FAPP Study 4)
Scientific Title Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine
Scientific Title:Acronym Japan FAP prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine (J-FAPP Study 4)
Region
Japan

Condition
Condition familial adenomatous polyposis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the colorectal tumor preventive effect of aspirin enteric coated tablet (100 mg/day) and/or mesalazine (2 g/day) in patients with familial adenomatous polyposis in a double-blind, 2 by 2 factorial design, 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 The primary endpoint is set as the incidence of recurrence / development of colorectal polyps that more than 5.0 mm in diameter after 8 months oral administration of low-dose aspirin and/or mesalazine.
Key secondary outcomes Maximum diameter and histology of the colorectal polyps more than 5.0 mm in size after 8 months oral administration of low-dose aspirin and/or mesalazine.
The change of all the number of the colorectal polyps smaller than 5.0 mm in diameter are compared between pre and post administration of low-dose aspirin and/or mesalazine. (The changes of polyp number are assessed by at least three medical specialists for colon endoscopy in a blinded manner with several endoscopic photographs in the cecum, the splenic flexure and the lower part of the rectum.)
The change of number of the upper gastrointestinal tumor, such as gastric adenoma and duodenal adenoma, are compared between pre and post administration of low-dose aspirin and/or mesalazine.
The occurrence of adverse events.
The incidence of recurrence /development of colorectal polyps more than 5.0 mm in diameter at 8-12 months after cessation of administration of low-dose aspirin and/or mesalazine.

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 adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 aspirin (100 mg/day) + mesalazine (2 g/day), for eight months
Interventions/Control_2 aspirin (100 mg/day) + placebo, for eight months
Interventions/Control_3 placebo + mesalazine (2 g/day), for eight months
Interventions/Control_4 placebo + placebo, for eight months
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 Candidate patients have to meet all the following inclusion criteria to participate in
the study.
# Patients with familial adenomatous polyposis (Participants in the J-FAPP Study III or the J-FAPP Study III-2).
# Familial adenomatous polyposis is defined as the presence of more than 100 adenomas in the colorectum including the past.
# The patients had been excised their all colorectal polyps more than 5.0 mm in diameter by endoscopy before the trial starts.
# The patients who could receive the last endoscopy examination performed 8 months after administration of low-dose aspirin and/or mesalazine.
Key exclusion criteria # Patients currently taking antithrombotics such as Bayaspirin, Panaldine, Warfarin and Persantin etc.
# Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study).
# Patients with a history of stroke including transient ischemic attack.
# 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)
# Patients with inflammatory bowel disease (ulcerative colitis, Crohn syndrome), bleeding diverticulosis, bleeding gastritis.
# Patients with bleeding tendency, a platelet count of < 100,000 /mm3, or with abnormal prothrombin time, or white blood cell count of 3,000 /mm3.
# Patients with any existing cancer at the time of participation in the trial, excluding radical cure of cancer, thyroid cancer and prostate cancer.
# Patients currently taking anticancer drugs.
# Patients with known allergy to aspirin or mesalazine.
# Women who are or may be pregnant during the study period.
# Patients currently taking NSAIDs at least 3 times weekly, for example, as an analgesic.
# Patients who took NSAIDs, such as sulindac, for the purpose of cancer chemoprevention but not pass 6 months at the time of the trial start. (Patients taking a lactic acid products such as BIOLACTIS POWDER; are allowed to participate in the trial.)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Ishikawa
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular-Targeting Cancer Prevention
Zip code 541-0042
Address 3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL 06-6202-5444
Email cancer@gol.com

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Ishikawa
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular-Targeting Cancer Prevention
Zip code 541-0042
Address 3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL 06-6202-5444
Homepage URL
Email cancer@gol.com

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine
Address 602-8566 Kyoto-shi, Kamigyo-ku Kajii-cho
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

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 がん研有明病院(東京)
国立がん研究センター東病院(千葉県)
石川消化器内科(大阪府)
埼玉医科大学総合医療センター(埼玉県)
兵庫医科大学病院(兵庫県)
近畿大学医学部附属病院(大阪府)
群馬中央総合病院(群馬県)
栃木県立がんセンター(栃木県)
東邦大学医療センター大橋病院(東京都)
札幌医科大学附属病院(北海道)
佐野病院(兵庫県)
徳島大学病院(徳島県)
大阪府立成人病センター(大阪府)
愛知県がんセンター中央病院(愛知県)
東芝病院(東京都)
広島大学病院(広島県)
岩国医療センター(山口県)
兵庫医科大学(兵庫県)
石川県立中央病院(石川県)
国立がん研究センター中央病院(東京都)
福岡山王病院国際医療福祉大学(福岡県)
四国がんセンター(愛媛県)
京都大学医学部附属病院(京都府)
医療法人彩樹守口敬任会病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 21 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 102
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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 18 Day
Date of IRB
2015 Year 08 Month 18 Day
Anticipated trial start date
2015 Year 09 Month 07 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 27 Day
Date trial data considered complete
2019 Year 03 Month 27 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 20 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/03/27 JFAPP4:全データ UMIN登録用 190327.xlsx


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