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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00212732
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Further study details as provided by Ono Pharmaceutical Co. Ltd:

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
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  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 Pharmaceutical Co. Ltd
Investigators
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00212732     History of Changes
Other Study ID Numbers: ONO-8025-08
Study First Received: September 13, 2005
Last Updated: October 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-8025, KRP-197, overactive bladder, antimuscarinic

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013