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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:
NCT00212706
First received: September 13, 2005
Last updated: October 11, 2012
Last verified: October 2012

September 13, 2005
October 11, 2012
October 2001
November 2002   (final data collection date for primary outcome measure)
Total number of urinary incontinence episodes per week
Same as current
Complete list of historical versions of study NCT00212706 on ClinicalTrials.gov Archive Site
Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL
Same as current
Not Provided
Not Provided
 
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Overactive Bladder
Drug: ONO-8025 (KRP-197)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Not Provided
November 2002   (final data collection date for primary outcome measure)

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 exclusion criteria as specified in the study protocol
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00212706
ONO-8025-06
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP