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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

Drug Information available for: 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:
  • Total number of urinary incontinence episodes per week

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with genuine stress incontinence
  2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
  3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
  4. Patients suffering from complications for which anticholinergics are contraindicated
  5. 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
Study 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
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:
Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009