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A Phase II Study of KUC-7483 in Patients With Overactive Bladder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742833
First Posted: August 28, 2008
Last Update Posted: September 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
August 5, 2008
August 28, 2008
September 4, 2009
Not Provided
Not Provided
Change from baseline in mean number of micturitions per 24 hours [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00742833 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: 12 weeks ]
  • Change from baseline in mean number of incontinence episodes per 24 hours [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
A Phase II Study of KUC-7483 in Patients With Overactive Bladder
A Randomized, Double Blind, Placebo Controlled, Phase II Study of KUC-7483 in Patients With Overactive Bladder
To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Overactive Bladder (OAB)
  • Drug: KUC-7483
  • Drug: Placebo
  • Experimental: 3
    Intervention: Drug: KUC-7483
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
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
Not Provided

Inclusion Criteria:

  • Patients with a symptom of overactive bladder for more than 6 months.
  • Patients who meet the following condition during the 3-day bladder diary period.

    • the mean number of micturitions per 24 hours is ≥8 times
    • the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion Criteria:

  • Patients who are diagnosed as stress urinary incontinence are predominant.
  • Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00742833
KUC1203
No
Not Provided
Not Provided
Not Provided
Kissei Pharmaceutical Co., Ltd.
Not Provided
Study Director: Yasuhiro Omori Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
September 2009

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