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

This study has been completed.

First Received: September 13, 2005 Last Updated: April 5, 2006 History of Changes

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00212732

Purpose

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

Condition	Intervention	Phase
Overactive Bladder	Drug: ONO-8025 (KRP-197)	Phase III

Drug Information available for: Imidafenacin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

Secondary Outcome Measures:

Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL

Estimated Enrollment:	750
Study Start Date:	October 2003

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212732

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Project Leader, Development Planning

Ono Pharma

More Information

No publications provided

Study ID Numbers:	ONO-8025-08
Study First Received:	September 13, 2005
Last Updated:	April 5, 2006
ClinicalTrials.gov Identifier:	NCT00212732 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

ONO-8025, KRP-197, overactive bladder, antimuscarinic

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive

Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 07, 2009