Back to resultsA Study of YM178 in Subjects With Symptoms of Overactive Bladder
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
YM178
Placebo
tolterodine ER
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Micturition, YM178, Urinary incontinence, Frequency, Overactive Bladder, Urgency, Urinary urge incontinence
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
YM178 group
placebo group
tolterodine ER group
Arm Description
oral
oral
oral
Outcomes
Primary Outcome Measures
Change in mean number of micturitions per 24 hrs
Secondary Outcome Measures
Change in mean number of urgency episodes per 24 hrs
Change in mean number of urinary incontinence episodes per 24 hrs
Change in mean number of urge incontinence episodes per 24 hrs
Change in mean volume voided per micturition
Change in mean number of nocturia episodes
Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01043666
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Micturition, YM178, Urinary incontinence, Frequency, Overactive Bladder, Urgency, Urinary urge incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YM178 group
Arm Type
Experimental
Arm Description
oral
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
oral
Arm Title
tolterodine ER group
Arm Type
Experimental
Arm Description
oral
Intervention Type
Drug
Intervention Name(s)
YM178
Other Intervention Name(s)
mirabegron
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
tolterodine ER
Other Intervention Name(s)
Detrusitol SR
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change in mean number of micturitions per 24 hrs
Time Frame
Within a 12-week treatment period
Secondary Outcome Measure Information:
Title
Change in mean number of urgency episodes per 24 hrs
Time Frame
Within a 12-week treatment period
Title
Change in mean number of urinary incontinence episodes per 24 hrs
Time Frame
Within a 12-week treatment period
Title
Change in mean number of urge incontinence episodes per 24 hrs
Time Frame
Within a 12-week treatment period
Title
Change in mean volume voided per micturition
Time Frame
Within a 12-week treatment period
Title
Change in mean number of nocturia episodes
Time Frame
Within a 12-week treatment period
Title
Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume
Time Frame
During 12-week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=168
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
A Study of YM178 in Subjects With Symptoms of Overactive Bladder
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