A Study of YM178 in Subjects With Symptoms of Overactive Bladder
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
1 other identifier
interventional
1,126
4 countries
35
Brief Summary
This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2009
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2009
CompletedFirst Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2011
CompletedOctober 31, 2024
October 1, 2024
1.7 years
January 5, 2010
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean number of micturitions per 24 hrs
Within a 12-week treatment period
Secondary Outcomes (6)
Change in mean number of urgency episodes per 24 hrs
Within a 12-week treatment period
Change in mean number of urinary incontinence episodes per 24 hrs
Within a 12-week treatment period
Change in mean number of urge incontinence episodes per 24 hrs
Within a 12-week treatment period
Change in mean volume voided per micturition
Within a 12-week treatment period
Change in mean number of nocturia episodes
Within a 12-week treatment period
- +1 more secondary outcomes
Study Arms (3)
YM178 group
EXPERIMENTALoral
placebo group
PLACEBO COMPARATORoral
tolterodine ER group
EXPERIMENTALoral
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Beijing, China
Unknown Facility
Dalian, China
Unknown Facility
Fuzhou, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Hubei, China
Unknown Facility
Hunan, China
Unknown Facility
Jiangsu, China
Unknown Facility
Liaoning, China
Unknown Facility
Nanjing, China
Unknown Facility
Shanghai, China
Unknown Facility
Ahmedabad, India
Unknown Facility
Gūrgaon, India
Unknown Facility
Jaipur, India
Unknown Facility
Lucknow, India
Unknown Facility
New Delhi, India
Unknown Facility
Pune, India
Unknown Facility
Busan, South Korea
Unknown Facility
Chungcheong Namdo, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Daejeon, South Korea
Unknown Facility
Gwangju, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Jeollabuk, South Korea
Unknown Facility
Jeollanam, South Korea
Unknown Facility
Kyonggi, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Chiayi City, Taiwan
Unknown Facility
Hualien City, Taiwan
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan District, Taiwan
Related Publications (1)
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.
PMID: 37160401DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 7, 2010
Study Start
December 21, 2009
Primary Completion
September 16, 2011
Study Completion
September 16, 2011
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.