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

Sponsor

Kissei Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01004315

Collaborator

(none)

750

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: KUC-7483 Drug: Placebo Drug: Tolterodine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KUC-7483	Drug: KUC-7483
Placebo Comparator: Placebo	Drug: Placebo
Active Comparator: Tolterodine	Drug: Tolterodine

Arm

Intervention/Treatment

Experimental: KUC-7483

Drug: KUC-7483

Placebo Comparator: Placebo

Drug: Placebo

Active Comparator: Tolterodine

Drug: Tolterodine

Outcome Measures

Primary Outcome Measures

Change from baseline in the mean number of micturitions per 24 hours [12 weeks]

Secondary Outcome Measures

Change from baseline in the mean number of urgency episodes per 24 hours [12 weeks]
Change from baseline in the mean number of incontinence episodes per 24 hours [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.