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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009363
Receipt No. R000011003
Scientific Title Preliminary/exploratory study on the inhibitory effect of time-dependent mesalazine on the formation of polyps in patients with familial adenomatous polyposis
Date of disclosure of the study information 2012/11/24
Last modified on 2014/05/02

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Basic information
Public title Preliminary/exploratory study on the inhibitory effect of time-dependent mesalazine on the formation of polyps in patients with familial adenomatous polyposis
Acronym Mesalazine polyp-inhibition study
Scientific Title Preliminary/exploratory study on the inhibitory effect of time-dependent mesalazine on the formation of polyps in patients with familial adenomatous polyposis
Scientific Title:Acronym Mesalazine polyp-inhibition study
Region
Japan

Condition
Condition Familial adenomatous polyposis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the polyp regression effect of mesalazine in Japanese patients with familial adenomatous polyposis and to examine the feasibility to conduct randomized trials.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Comparison of the size of colorectal polyps post administration to that at baseline.
Key secondary outcomes Below items are compared between pre and post administration of mesalazine.
number of colorectal polyps, sites of polyps, adverse events, size and number of polyps (fundic gland polyp, gastric adenoma (gastric, intestinal type), duodenal adenoma, thyroid tumor, gallbladder polyp, desmoids).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 6 months oral administration of time-dependent release mesalazine 4g/day (2g twice daily).
Interventions/Control_2
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who need colonoscopic examination at least once a half year
Key exclusion criteria 1) Patients who take mesalamine or sulphasalazine within two weeks before the registration.
2) Patients who have possibility to take NSAIDs (non-steroidal anti-inflammatory drugs) constantly during the study period.
3) Patients who have high possibility to be applied colectomy during the study period.
4) Patients with hypersensitivity to salicylic acid drug or mesalazine formulations.
5) Patients who have experienced serious adverse events due to mesalazine.
6) Women who are or may be pregnant during the study period.
7) Patients with side effects by other previous clinical studies.
8) Patients who were considered unsuitable for this study by investigator

Target sample size 6

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

Sponsor
Institute Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Local Government
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 石川消化器内科(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 24 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
2012 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 24 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 19 Day
Last modified on
2014 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011003

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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