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

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

This study has been completed.

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

ChemIDplus related topics:

Imidafenacin

U.S. FDA Resources

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

Study ID Numbers:	ONO-8025-08
First Received:	September 13, 2005
Last Updated:	April 5, 2006
ClinicalTrials.gov Identifier:	NCT00212732
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:

Signs and Symptoms

Urinary Bladder, Overactive

Urologic Diseases

Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on October 07, 2008