A Confirmatory Study of KUC-7483 in Patients With Overact... | NCT01004315

Studies
A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

NCT01004315

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jul 27, 2010Estimated

Enrollment

750Estimated

Phase

Phase 3

Conditions

Overactive Bladder

Interventions

KUC-7483
Placebo
Tolterodine

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 27, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2010

Last Update Posted Date

Jul 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Label	Type	Intervention Names
KUC-7483	Experimental	Drug: KUC-7483
Placebo	Placebo Comparator	Drug: Placebo
Tolterodine	Active Comparator	Drug: Tolterodine

Name	Type	Description	Arm Group Labels	Other Names
KUC-7483	Drug		KUC-7483
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the mean number of micturitions per 24 hours		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in the mean number of urgency episodes per 24 hours		12 weeks
Change from baseline in the mean number of incontinence episodes per 24 hours		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a symptom of overactive bladder for more than 6 months.
Patients who meet the following condition during the 3-day bladder diary period.
- the mean number of micturitions per 24 hours is ≥8 times
- the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion Criteria:

Patients who are diagnosed as stress urinary incontinence are predominant.
Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasuhiro Omori	Clinical Development Department, Kissei pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Japan		Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu			Japan

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive
D053202	Urinary Incontinence, Urge

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C576375	ritobegron ethyl
D000068737	Tolterodine Tartrate

Ancestor Terms

ID	Term
D010665	Phenylpropanolamine
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided