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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-24

Study Completion Date

2010-02-15

Brief Summary

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

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Detailed Description

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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).

Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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YM178 group

oral

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

oral

Placebo group

oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

tolterodine group

oral

Group Type ACTIVE_COMPARATOR

tolterodine

Intervention Type DRUG

oral

Interventions

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YM178

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

tolterodine

oral

Intervention Type DRUG

Other Intervention Names

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mirabegron Detrol Detrusitol

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No