Clinical trial NCT00966004: A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder
Official title: Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Urge incontinence
YM178
Overactive Bladder
Urgency
Urinary incontinence
mirabegron
Micturition
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 1139
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 YM178 over those of tolterodine, the control drug, without a non-inferiority test.

The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change from baseline in the mean number of micturitions per 24 hours
timeFrame: Within a 12-week treatment period
Secondary outcomes:
measure: Change from baseline in the mean number of urgency episodes per 24 hours
timeFrame: Within a 12-week treatment period
measure: Change from baseline in the mean number of urinary incontinence episode per 24 hours
timeFrame: Within a 12-week treatment period
measure: Change from baseline in the mean number of urge incontinence episodes per 24 hours
timeFrame: Within a 12-week treatment period
measure: Change from baseline in the mean volume voided per micturition
timeFrame: Within a 12-week treatment period
measure: Change from baseline in mean number of nocturia episodes
timeFrame: Within a 12-week treatment period
measure: Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire
timeFrame: Within a 12-week treatment period
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Kantou
country: Japan
city: Kinki
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: