臨床研究等提出・公開システム

Date of registration	Dec. 13, 2018
Last modified on	June. 13, 2020
Trial ID	jRCT2080224187

Scientific Title	A repeatedly applied study of BBI-4000 in patients with primary hyperhidrosis
Public Title	A repeatedly applied study of BBI-4000 in patients with primary hyperhidrosis

Completion Date or Terminated date	April. 03, 2019
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	KAKEN PHARMACEUTICAL, CO., LTD.
	Address
	Phone Number
	E-mail Address	akamatsu_motoki@kaken.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	KAKEN PHARMACEUTICAL, CO., LTD.
	Address
	Phone Number
	E-mail Address	akamatsu_motoki@kaken.co.jp

Recruitment Status	completed

Date of First Enrolment		Jan. 19, 2019
Target Sample Size		25
Study Type		Interventional
Study Design	Study Design	Open
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Patients diagnosed as primary axillary hyperhidrosis
	Exclusion Criteria	Secondary hyperhidrosis
	Minimum Age	20age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		Primary axillary hyperhidrosis
Intervention(s)		investigational material(s) Generic name etc : BBI-4000 INN of investigational material : sofpironium bromide Therapeutic category code : 129 Other agents affecting peripheral nervous system Dosage and Administration for Investigational material : Once per day control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		pharmacokinetics Plasma BBI-4000 level
Secondary Outcome		safety Adverse event

Primary Sponsor	KAKEN PHARMACEUTICAL, CO., LTD.
Secondary Sponsor	-

Name of Funding Organization	KAKEN PHARMACEUTICAL, CO., LTD.
Name of Research Funding	-

Name of IRB	Hakata clinic IRB
Address of IRB	6-18, Tenya-machi, Hakata-ku, Fukuoka, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Dec. 07, 2018

Secondary ID No.	JapicCTI-184249
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	June. 13, 2020	(this page)	Changes
2	April. 17, 2019	Detail	Changes
1	Dec. 13, 2018	Detail

List of change history