UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009363 |
|---|---|
| Receipt number | 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 15:53:05 |
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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
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
cancer@gol.com
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011003
