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

Phase 2CompletedNCT00742833

Kissei Pharmaceutical Co., Ltd.400 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Overactive Bladder (OAB)

Interventions

KUC-7483DRUG

PlaceboDRUG

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 (6)

Japan

Hokkaido Region, Japan

Japan

Kansai Region, Japan

Japan

Kanto Region, Japan

Japan

Kyushu Region, Japan

Japan

Shikoku Region, Japan

Outcomes

Primary Outcomes

Change from baseline in mean number of micturitions per 24 hours

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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