Urinary Bladder, Overactive Clinical Trial
Official title:
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
Verified date | February 2017 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.
Status | Completed |
Enrollment | 1126 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
China, India, Korea, Republic of, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mean number of micturitions per 24 hrs | Within a 12-week treatment period | ||
Secondary | Change in mean number of urgency episodes per 24 hrs | Within a 12-week treatment period | ||
Secondary | Change in mean number of urinary incontinence episodes per 24 hrs | Within a 12-week treatment period | ||
Secondary | Change in mean number of urge incontinence episodes per 24 hrs | Within a 12-week treatment period | ||
Secondary | Change in mean volume voided per micturition | Within a 12-week treatment period | ||
Secondary | Change in mean number of nocturia episodes | Within a 12-week treatment period | ||
Secondary | Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume | During 12-week treatment |
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