Status:
COMPLETED
A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.
Detailed Description
This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM17...
Eligibility Criteria
Inclusion
- Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period
- Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
- Patient with an average frequency of micturition of 8 or more times per 24-hour period
- Written informed consent has been obtained
Exclusion
- Patients without experience of urge incontinence before informed consent
- Patients given a clear diagnosis of stress incontinence
- Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)
- Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis
- Patients with a previous history of recurrent urinary tract infection
- Patients complicated with or with a history of bladder tumor or prostatic tumor
- Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease
- Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period
- Patients with an indwelling catheter or practicing intermittent self-catheterization
- Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia
- Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period
- Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or \< 50 bpm
- Patients with polyuria exceeding 3000 mL in mean daily urine volume
- Patients meeting any of the following in the examinations
- Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee
- Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)
- Patients with a blood creatinine level ≥ 2.0 mg/dL
Key Trial Info
Start Date :
July 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2010
Estimated Enrollment :
1139 Patients enrolled
Trial Details
Trial ID
NCT00966004
Start Date
July 24 2009
End Date
February 15 2010
Last Update
October 31 2024
Active Locations (4)
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1
Chūbu, Japan
2
Kantou, Japan
3
Kinki, Japan
4
Kyushu, Japan