A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00966004

Collaborator

(none)

1,139

Enrollment

Locations

Arms

7.1

Duration (Months)

284.8

Patients Per Site

40.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder, Overactive	Drug: YM178 Drug: Placebo Drug: tolterodine	Phase 3

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

1139 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: YM178 group oral	Drug: YM178 oral Other Names: mirabegron
Placebo Comparator: Placebo group oral	Drug: Placebo oral
Active Comparator: tolterodine group oral	Drug: tolterodine oral Other Names: Detrol Detrusitol

Arm

Intervention/Treatment

Experimental: YM178 group

oral

Drug: YM178

oral

Other Names:

mirabegron

Placebo Comparator: Placebo group

oral

Drug: Placebo

oral

Active Comparator: tolterodine group

oral

Drug: tolterodine

oral

Other Names:

Detrol

Detrusitol

Outcome Measures

Primary Outcome Measures

Change from baseline in the mean number of micturitions per 24 hours [Within a 12-week treatment period]

Secondary Outcome Measures

Change from baseline in the mean number of urgency episodes per 24 hours [Within a 12-week treatment period]
Change from baseline in the mean number of urinary incontinence episode per 24 hours [Within a 12-week treatment period]
Change from baseline in the mean number of urge incontinence episodes per 24 hours [Within a 12-week treatment period]
Change from baseline in the mean volume voided per micturition [Within a 12-week treatment period]
Change from baseline in mean number of nocturia episodes [Within a 12-week treatment period]
Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire [Within a 12-week treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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