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

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00742833
First received: August 5, 2008
Last updated: September 2, 2009
Last verified: September 2009

August 5, 2008
September 2, 2009
Not Provided
Not Provided
Change from baseline in mean number of micturitions per 24 hours [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of incontinence episodes per 24 hours [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00742833
KUC1203
No
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