臨床研究等提出・公開システム

Date of registration	Aug. 20, 2021
Last modified on	Jan. 27, 2025
Trial ID	jRCT2031210266

Scientific Title	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of SR-0379 in Participants with Skin Ulcer
Public Title	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of SR-0379 in Participants with Skin Ulcer

Contact for Scientific Queries	Name	Ichioka Shigeru
	Affiliation	Saitama Medical University Hospital
	Address	38 Morohongo Moroyama-machi, Iruma-gun
	Telephone	+81-492-76-1299
	E-mail	ichioka2006@yahoo.co.jp
Contact for Public Queries	Name	Tomioka Hideki
	Affiliation	FunPep Co., Ltd.
	Address	Office for University-Industry Collaboration Bldg. A, 5F No.509, Osaka University 2-1 Yamadaoka, Suita, Osaka
	Telephone	+81-6-6369-7957
	E-mail	htomioka@funpep.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 02, 2021
Target sample size		120
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients must have a wound requiring wound bed preparation in advance of planned surgical closure (including suturing, grafts or flaps)
	Exclusion Criteria	Presence of untreated ulcer infection (redness, swelling, pus, foul odor, fever)
	Age Minimum	18age old over
	Age Maximum	85age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		skin ulcer
Intervention(s)		SR-0379 or placebo spray
Primary Outcome(s)		The days to simple surgical intervention (ncluding suturing, grafts or flaps)

Primary Sponsor	FunPep Co., Ltd.

Name of Certified Review Board	Saitama Medical University Hospital Clinical Trial
Address	38 Morohongo Moroyama-machi, Iruma-gun, Saitama
Telephone	+81-49-276-1454
E-Mail	tikens@saitama-med.ac.jp
Approval Status	Approval
Date of approval	July. 01, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Jan. 27, 2025	(this page)	Changes
3	Mar. 03, 2023	Detail	Changes
2	Mar. 10, 2022	Detail	Changes
1	Aug. 20, 2021	Detail

List of change history