A Confirmatory 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:
NCT01004315
First received: October 27, 2009
Last updated: July 25, 2010
Last verified: July 2010

October 27, 2009
July 25, 2010
Not Provided
Not Provided
Change from baseline in the 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 NCT01004315 on ClinicalTrials.gov Archive Site
  • Change from baseline in the mean number of urgency episodes per 24 hours [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the 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 Confirmatory Study of KUC-7483 in Patients With Overactive Bladder
A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder

To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: KUC-7483
  • Drug: Placebo
  • Drug: Tolterodine
  • Experimental: KUC-7483
    Intervention: Drug: KUC-7483
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Tolterodine
    Intervention: Drug: Tolterodine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
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
 
NCT01004315
KUC1301
No
Not Provided
Kissei Pharmaceutical Co., Ltd.
Not Provided
Study Director: Yasuhiro Omori Clinical Development Department, Kissei pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
July 2010

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