Long-term Safety and Efficacy of Imidafenacin in Patients... | NCT00512785

Studies
Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

NCT00512785

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 13, 2012Estimated

Enrollment

435Actual

Phase

Phase 3

Conditions

Overactive Bladder

Interventions

imidafenacin, KRP-197/ONO-8025
imidafenacin, KRP-197/ONO-8025

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

Jun 2012

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

Aug 2007

Primary Completion Date

May 2009Actual

Completion Date

Not provided

First Submitted Date

Aug 7, 2007

First Submission Date that Met QC Criteria

Aug 7, 2007

First Posted Date

Aug 8, 2007Estimated

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

Jun 12, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Name	Class
Kyorin Pharmaceutical Co.,Ltd	INDUSTRY

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

435Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E1	Experimental		Drug: imidafenacin, KRP-197/ONO-8025
E2	Experimental		Drug: imidafenacin, KRP-197/ONO-8025

Interventions

Name	Type	Description	Arm Group Labels	Other Names
imidafenacin, KRP-197/ONO-8025	Drug	0.1 mg BID for 52 weeks	E1
imidafenacin, KRP-197/ONO-8025

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume		64 weeks

Secondary Outcomes

Measure	Description	Time Frame
Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life		64 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and Woman equal or > 20 years old
Patients with urgency, urinary frequency and urgency incontinence

Exclusion Criteria:

Patients with genuine stress incontinence
Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
Patients suffering from complications contraindicating the use of antimuscarinic medication
Patients with polyuria

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
Yoshifumi Hirahara	Kyorin Pharmaceutical Co.,Ltd	Study Director
Toshihiko Konomi	Ono Pharmaceutical Co., Ltd.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanto Region		Kanto			Japan
Kinki Region

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

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
C120953	imidafenacin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided