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

Phase 3CompletedNCT01004315

Kissei Pharmaceutical Co., Ltd.750 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

750

Conditions

Overactive Bladder

Interventions

KUC-7483DRUG

PlaceboDRUG

TolterodineDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Japan

Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu, Japan

Outcomes

Primary Outcomes

Change from baseline in the mean number of micturitions per 24 hours

Time frame: 12 weeks

Secondary Outcomes

Change from baseline in the mean number of urgency episodes per 24 hours

Time frame: 12 weeks

Change from baseline in the mean number of incontinence episodes per 24 hours

Time frame: 12 weeks

Data from ClinicalTrials.gov

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