A Study of YM178 in Subjects With Symptoms of Overactive Bladder
NCT ID: NCT01043666
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1126 participants
INTERVENTIONAL
2009-12-21
2011-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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YM178 group
oral
YM178
oral
placebo group
oral
Placebo
oral
tolterodine ER group
oral
tolterodine ER
oral
Interventions
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YM178
oral
Placebo
oral
tolterodine ER
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Beijing, , China
Dalian, , China
Fuzhou, , China
Guangzhou, , China
Hangzhou, , China
Hubei, , China
Hunan, , China
Jiangsu, , China
Liaoning, , China
Nanjing, , China
Shanghai, , China
Ahmedabad, , India
Gurgaon, , India
Jaipur, , India
Lucknow, , India
New Delhi, , India
Pune, , India
Busan, , South Korea
Chungcheong Namdo, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Jeollabuk, , South Korea
Jeollanam, , South Korea
Kyonggi, , South Korea
Seoul, , South Korea
Chiayi City, , Taiwan
Hualien City, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Countries
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References
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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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178-CL-090
Identifier Type: -
Identifier Source: org_study_id
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