A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004315
• Other study ID #: KUC1301
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2009
• Last updated: July 25, 2010

Study information

• Verified date: July 2010
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• KUC-7483

• Placebo

• Tolterodine

Locations

Country	Name	City	State
Japan	Japan	Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the mean number of micturitions per 24 hours		12 weeks	No
Secondary	Change from baseline in the mean number of urgency episodes per 24 hours		12 weeks	No
Secondary	Change from baseline in the mean number of incontinence episodes per 24 hours		12 weeks	No