A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

Astellas Pharma Inc1,139 enrolled

Overview

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test. The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,139

Conditions

Urinary Bladder, Overactive

Interventions

YM178DRUG

oral

PlaceboDRUG

oral

tolterodineDRUG

oral

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period * Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself * Patient with an average frequency of micturition of 8 or more times per 24-hour period * Written informed consent has been obtained Exclusion Criteria: * Patients without experience of urge incontinence before informed consent * Patients given a clear diagnosis of stress incontinence * Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc) * Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis * Patients with a previous history of recurrent urinary tract infection * Patients complicated with or with a history of bladder tumor or prostatic tumor * Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease * Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period * Patients with an indwelling catheter or practicing intermittent self-catheterization * Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia * Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period * Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or \< 50 bpm * Patients with polyuria exceeding 3000 mL in mean daily urine volume * Patients meeting any of the following in the examinations * Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee * Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L) * Patients with a blood creatinine level ≥ 2.0 mg/dL

Locations (4)

Unnamed facility

Chūbu, Japan

Unnamed facility

Kantou, Japan

Unnamed facility

Kinki, Japan

Unnamed facility

Kyushu, Japan