A Study of YM178 in Subjects With Symptoms of Overactive Bladder
- Conditions
- Health Condition 1: N329- Bladder disorder, unspecifiedHealth Condition 2: null- Symptoms of overactive bladder
- Registration Number
- CTRI/2010/091/000535
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1300
Ages Eligible for Study: 18 Years and older,
Genders Eligible for Study: Both,
Accepts Healthy Volunteers: No.
Inclusion Criteria:
1. Subjects with symptoms of overactive bladder for at least 12 weeks before the study
2. Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
3. Subject with an average frequency of micturition of 8 or more times per 24-hour period
4. Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
5. Subject having provided written informed consent by him/herself
1. Subject having stress urinary incontinence as a predominant symptom
2. Subject with transient symptoms suspected for overactive bladder
3. Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
4. Subject complicated with bladder tumor/prostatic tumor or with the historical condition
5. Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease
6. Subject with indwelling catheter or practicing intermittent self-catheterization
7. Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
8. Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
9. Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg)
10. Subject with a pulse rate >= 110bpm or <50 bpm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean number of micturitions per 24 hrsTimepoint: Time Frame: Within a 12-week treatment period
- Secondary Outcome Measures
Name Time Method Change in mean number of nocturia episodesTimepoint: Time Frame: Within a 12-week treatment period;Change in mean number of urge incontinence episodes per 24 hrsTimepoint: Time Frame: Within a 12-week treatment period;Change in mean number of urgency episodes per 24 hrsTimepoint: Time Frame: Within a 12-week treatment period;Change in mean number of urinary incontinence episodes per 24 hrsTimepoint: Time Frame: Within a 12-week treatment period;Change in mean volume voided per micturitionTimepoint: Time Frame: Within a 12-week treatment period;Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volumeTimepoint: Time Frame: During 12-week treatment