Urinary Bladder, Overactive Clinical Trial
Official title:
Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder
Verified date | February 2017 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.
Status | Completed |
Enrollment | 1139 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the mean number of micturitions per 24 hours | Within a 12-week treatment period | ||
Secondary | Change from baseline in the mean number of urgency episodes per 24 hours | Within a 12-week treatment period | ||
Secondary | Change from baseline in the mean number of urinary incontinence episode per 24 hours | Within a 12-week treatment period | ||
Secondary | Change from baseline in the mean number of urge incontinence episodes per 24 hours | Within a 12-week treatment period | ||
Secondary | Change from baseline in the mean volume voided per micturition | Within a 12-week treatment period | ||
Secondary | Change from baseline in mean number of nocturia episodes | Within a 12-week treatment period | ||
Secondary | Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire | Within a 12-week treatment period |
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