UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for the effect of the reinforcing material on the treatment for the patients with inflammatory bowel disease.
Title of the study (Brief title)	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	Mamoru Watanabe
Organization	Tokyo Medical and Dental University
Division name	Gastroenterology and Hepatology
Address	1-5-45, Yushima Bunkyo-ku, Tokyo
TEL	03-5803-5973
Email	mamoru.gast@tmd.ac.jp

Public contact
Name of contact person	Kiichiro Tsuchiya
Organization	Tokyo Medical and Dental University
Division name	Advanced Therapeutics for Gastrointestinal Diseases
Address	1-5-45, Yushima Bunkyo-ku, Tokyo
TEL	03-5803-5974
Homepage URL
Email	kii.gast@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015806