NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-184249

Registered date:13/12/2018

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

Basic Information

Public titleA repeatedly applied study of BBI-4000 in patients with primary hyperhidrosis
Scientific titleA repeatedly applied study of BBI-4000 in patients with primary hyperhidrosis
Recruitment statuscomplete
Health condition(s) or Problem(s) studiedPrimary axillary hyperhidrosis
Study typeINTERVENTIONAL
Phase
Study design
Intervention(s)Intervention name : BBI-4000 INN of the intervention : sofpironium bromide Dosage And administration of the intervention : Once per day Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -
Sample Size25
Date of first enrollment19/1/2019
Completion dateNone
Countries of recruitmentJapan

Outcome(s)

Primary Outcomepharmacokinetics Plasma BBI-4000 level
Secondary Outcomesafety Adverse event

Key inclusion & exclusion criteria

Age minimum20
Age maximum65
GenderBOTH
Include criteriaPatients diagnosed as primary axillary hyperhidrosis
Exclude criteriaSecondary hyperhidrosis

Related Information

Primary SponsorKAKEN PHARMACEUTICAL, CO., LTD.
Secondary-
Source(s)KAKEN PHARMACEUTICAL, CO., LTD.

Secondary Identifiers

Secondary ID

Contact

public contact
Name KAKEN PHARMACEUTICAL, CO., LTD. Clinical Development Department
Address
Telephone
E-mail akamatsu_motoki@kaken.co.jp
Affiliation
scientific contact
Name KAKEN PHARMACEUTICAL, CO., LTD. Clinical Development Department
Address
Telephone
E-mail akamatsu_motoki@kaken.co.jp
Affiliation

Ethics Reviews

StatusApproved
Approval Date07/12/2018
Contact NameHakata clinic IRB
Contact Address6-18, Tenya-machi, Hakata-ku, Fukuoka, Japan
Contact Phone
Contact Email

Summary Results

Date of posting of results summaries
Date of the first journal publication of results
URL hyperlink(s) related to results and publications
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Brief Summary
URL link to protocol file(s) with version and date

IPD sharing statement

Plan to share IPDNo
Plan description