UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013524 |
|---|---|
| Receipt number | R000015806 |
| Scientific Title | The study for the effect of the reinforcing material on the treatment for the patients with inflammatory bowel disease. |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2018/09/28 12:38:48 |
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Basic information
Public title
The study for the effect of the reinforcing material on the treatment for the patients with inflammatory bowel disease.
Acronym
The study for the effect of the reinforcing material on the treatment for the patients with IBD.
Scientific Title
The study for the effect of the reinforcing material on the treatment for the patients with inflammatory bowel disease.
Scientific Title:Acronym
The study for the effect of the reinforcing material on the treatment for the patients with IBD.
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of the treatment with reinforcing material for intestinal ulcer of the patients with inflammatory bowel disease is analyzed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The size of ulcer, mucosal healing by the endoscopic finding.
The structure of the villi and the degree of inflammation by the pathological findings of the biopsy specimen
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The cover of the reinforcing material on the refractory ulcer of the patients with IBD.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with IBD who has the ulcers in rectum by the endoscopy in spite of the therapy for IBD.
Key exclusion criteria
The patients with contraindications for the endoscopy and biopsy.
Pregnant patients or possible pregnant patients. The patients who have past history of the allergy to the reinforcing material. The patients who take medicines inducing the interaction with the reinforcing material.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Watanabe |
Organization
Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45, Yushima Bunkyo-ku, Tokyo
TEL
03-5803-5973
mamoru.gast@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiichiro Tsuchiya |
Organization
Tokyo Medical and Dental University
Division name
Advanced Therapeutics for Gastrointestinal Diseases
Zip code
Address
1-5-45, Yushima Bunkyo-ku, Tokyo
TEL
03-5803-5974
Homepage URL
kii.gast@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Research Center Network for Realization of Regenerative Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 26 | Day |
Last modified on
| 2018 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015806
