A Study of YM178 in Subjects With Symptoms of Overactive Bladder

Phase 3

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: YM178; Drug: Placebo; Drug: tolterodine ER

• Registration Number: NCT01043666
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2009-12-21
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Primary Completion: 2011-09-16
• Study Completion: 2011-09-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1126

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YM178 group	YM178	oral
placebo group	Placebo	oral
tolterodine ER group	tolterodine ER	oral

Primary Outcome Measures

Name	Time	Method
Change in mean number of micturitions per 24 hrs	Within a 12-week treatment period

Secondary Outcome Measures

Name	Time	Method
Change in mean number of urgency episodes per 24 hrs	Within a 12-week treatment period
Change in mean number of urge incontinence episodes per 24 hrs	Within a 12-week treatment period
Change in mean volume voided per micturition	Within a 12-week treatment period
Change in mean number of nocturia episodes	Within a 12-week treatment period
Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume	During 12-week treatment
Change in mean number of urinary incontinence episodes per 24 hrs	Within a 12-week treatment period