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A Study of YM178 in Subjects With Symptoms of Overactive Bladder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of YM178 in Subjects With Symptoms of Overactive Bladder

Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder

NCT01043666•Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with symptoms of overactive bladder for at least 12 weeks before the study
•Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
•Subject with an average frequency of micturition of 8 or more times per 24-hour period
•Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
•Subject having provided written informed consent by him/herself

Exclusion Criteria

•Subject having stress urinary incontinence as a predominant symptom
•Subject with transient symptoms suspected for overactive bladder
•Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
•Subject complicated with bladder tumor/prostatic tumor or with the historical condition
•Subject confirmed to have a post-void residual volume of \>=100ml or with a clinically significant lower urinary tract obstructive disease
•Subject with indwelling catheter or practicing intermittent self-catheterization
•Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
•Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
•Subject with uncontrolled hypertension (indicated by sitting SBP \>=180mmHg or DPB \>= 110mmHg)
•Subject with a pulse rate \>= 110bpm or \<50 bpm

Locations (35)

Beijing, China

Dalian, China

Fuzhou, China

Guangzhou, China

Hangzhou, China

Hubei, China

Hunan, China

Jiangsu, China

Liaoning, China

Nanjing, China

Key Dates

Start Date

December 21, 2009

Primary Completion Date

September 16, 2011

Completion Date

September 16, 2011

Last Updated

October 31, 2024

Enrollment

1,126

ACTUAL participants

Conditions

Urinary Bladder, Overactive

Interventions

YM178

DRUG

Placebo

DRUG

tolterodine ER

DRUG

Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

NCT07366918

Urinary Bladder, Overactive

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RECRUITING

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

NCT06933407

Urinary IncontinenceUrinary Incontinence, Stress+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of YM178 in Subjects With Symptoms of Overactive Bladder

Inclusion Criteria

Exclusion Criteria

Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

NXT Post-Market Clinical Follow-up

Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents