臨床研究等提出・公開システム

Japanese

Date of registration	June. 07, 2023
Last modified on	Aug. 07, 2025
Trial ID	jRCTs032230119

Scientific Title	A novel treatment for ulcerative colitis with purastat: A single-center prospective interventional study
Public Title	A novel treatment for ulcerative colitis with purastat

Contact for Scientific Queries	Name	Itoi Yuki
	Affiliation	Gunma University Graduate School of Medicine
	Address	3-39-15 Showa-machi, Maebashi
	Telephone	+81-27-220-8137
	E-mail	yuki.itoi.1990.10.09@gmail.com
Contact for Public Queries	Name	Itoi Yuki
	Affiliation	Gunma University Graduate School of Medicine
	Address	3-39-15 Showa-machi, Maebashi
	Telephone	+81-27-220-8137
	E-mail	yuki.itoi.1990.10.09@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 07, 2023
Actual date of first enrollment
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Ulcerative colitis between the ages of 18 and 85 at the time of enrollment 2) Patients with mild to moderate disease on the Partial Mayo score 3) Patients who understand the contents of the consent document and give free written consent
	Exclusion Criteria	1) Those with concurrent infectious or drug-induced enteritis 2) Pregnant or possibly pregnant 3) Those who are breast-feeding 4) Patients with abnormal blood coagulation function 5) Patients with severe organ failure 6) Other patients who are deemed unsuitable for registration by the physician in charge.
	Age Minimum	18age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ulcerative colitis
Intervention(s)		The study drug (Purastat) will be applied to the rectum under the lower gastrointestinal endoscope. A total of 3 subjects will be treated once and the safety results will be analyzed. After seeking the opinion of the efficacy and safety committee, the study drug will be administered to the remaining subjects every 4 weeks for a total of 3 doses.
Health Condition(s) Keyword		Inflammatory bowel disease
Intervention(s) Keyword		Purastat
Health Condition(s) Code		D003093
Intervention(s) Code
Primary Outcome(s)		Percentage improvement from baseline in Mayo endoscopic score at 2, 3, and 4 endoscopies and percentage of remission Improvement: decrease in Mayo endoscopic score from baseline Remission: 0 or 1 in Mayo endoscopic score
Secondary Outcome(s)		Improvement from baseline and remission rate of the following endpoints after treatment: Clinical severity (partial mayo score) Clinical severity (partial mayo score) Improvement: decrease of at least 1 point from baseline Remission: total of 2 points or less and none of the subscores exceed 1 Pathological severity (NANCY index) Improvement: decrease of at least 1 point from baseline Remission: NANCY index of 0 or 1 Change from baseline in the following endpoints after treatment (difference between pre and post values) :Hb, CRP, LRG

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	3D MATRIX
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	May. 23, 2023

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Aug. 07, 2025	(this page)	Changes
5	July. 04, 2025	Detail	Changes
4	Nov. 05, 2024	Detail	Changes
3	Mar. 08, 2024	Detail	Changes
2	July. 28, 2023	Detail	Changes
1	June. 07, 2023	Detail

List of change history