Controlled Study of ONO-8025 (KRP-197) in Patients With O... | NCT00212732

Studies
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

NCT00212732

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 11, 2012Estimated

Enrollment

750

Phase

Phase 3

Conditions

Overactive Bladder

Interventions

ONO-8025 (KRP-197)

Countries

Not provided

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

Oct 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

Oct 2003

Primary Completion Date

Apr 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 21, 2005Estimated

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

Oct 10, 2012

Last Update Posted Date

Oct 11, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

Detailed Description

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

750

Name	Type	Description	Arm Group Labels	Other Names
ONO-8025 (KRP-197)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total number of urinary incontinence episodes per week

Secondary Outcomes

Measure	Description	Time Frame
Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are 20 years old or over with overactive bladder
Total number of urinary incontinence episodes per week is 5 or over
Mean number of micturition per day is 8 or over
Mean number of urinary urgency episodes per day is 1 or over
Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

Patients with genuine stress incontinence
Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
Patients suffering from complications for which anticholinergics are contraindicated
Other exlcusion criteria as specified in the study protocol

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
Project Leader, Development Planning	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37160401	Derived	Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

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