臨床研究等提出・公開システム

Date of registration	Sept. 05, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220025

Scientific Title	CS-801 phase 3 comparative study
Public Title

Completion Date or Terminated date
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
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Double blind comparative study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Inclusion criteria: -Patient, age 20 years or older -Patients with urinary frequency and urge urinary incontinence Exclusion criteria: -Patients who have diseases such as dysuria or urinary retention -Patients who have difficulty to void for myself -Patients with other diseases which may have been related to the state of urination. (ex urinary tract infection) -Patients with polyuria -Patients with diseases for which treatment with anticholinergic agents is contraindicated -Patients in whom precautions are required for the use of anticholinergic agents -Patients who have difficulty to use transdermal medications
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender
Health Condition or Problem Studied		Overactive bladder
Intervention(s)		investigational material(s) Generic name etc : CS-801 INN of investigational material : Therapeutic category code : 259 Other agents for uro-genital and anal organ Dosage and Administration for Investigational material : Transdermal,Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy and safety
Secondary Outcome

Primary Sponsor	Sankyo Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-050025
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	April. 01, 2007	Detail	Changes
5	April. 01, 2007	Detail	Changes
4	Mar. 28, 2006	Detail	Changes
3	Mar. 28, 2006	Detail	Changes
2	Sept. 05, 2005	Detail	Changes
1	Sept. 05, 2005	Detail

List of change history