Clinical trial NCT01043666: A Study of YM178 in Subjects With Symptoms of Overactive Bladder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Micturition
YM178
Urinary incontinence
Frequency
Overactive Bladder
Urgency
Urinary urge incontinence
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-01-07
Enrollment: 1126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean number of micturitions per 24 hrs
timeFrame: Within a 12-week treatment period
Secondary outcomes:
measure: Change in mean number of urgency episodes per 24 hrs
timeFrame: Within a 12-week treatment period
measure: Change in mean number of urinary incontinence episodes per 24 hrs
timeFrame: Within a 12-week treatment period
measure: Change in mean number of urge incontinence episodes per 24 hrs
timeFrame: Within a 12-week treatment period
measure: Change in mean volume voided per micturition
timeFrame: Within a 12-week treatment period
measure: Change in mean number of nocturia episodes
timeFrame: Within a 12-week treatment period
measure: Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume
timeFrame: During 12-week treatment
Other outcomes:
Locations:
city: Beijing
country: China
city: Dalian
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Hubei
country: China
city: Hunan
country: China
city: Jiangsu
country: China
city: Liaoning
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Ahmedabad
country: India
city: Gurgaon
country: India
city: Jaipur
country: India
city: Lucknow
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Busan
country: Korea, Republic of
city: Chungcheong Namdo
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeollabuk
country: Korea, Republic of
city: Jeollanam
country: Korea, Republic of
city: Kyonggi
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Chia-Yi
country: Taiwan
city: Hualien
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: