A Study of YM178 in Subjects With Symptoms of Overactive Bladder

Urinary Bladder, Overactive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043666
• Other study ID #: 178-CL-090
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2010
• Last updated: February 14, 2017
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: February 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1126
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• YM178
oral
• Placebo
oral
• tolterodine ER
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean number of micturitions per 24 hrs		Within a 12-week treatment period
Secondary	Change in mean number of urgency episodes per 24 hrs		Within a 12-week treatment period
Secondary	Change in mean number of urinary incontinence episodes per 24 hrs		Within a 12-week treatment period
Secondary	Change in mean number of urge incontinence episodes per 24 hrs		Within a 12-week treatment period
Secondary	Change in mean volume voided per micturition		Within a 12-week treatment period
Secondary	Change in mean number of nocturia episodes		Within a 12-week treatment period
Secondary	Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume		During 12-week treatment

External Links

•   Link to results on Astellas Clinical Study Results website