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

Primary Purpose

Urinary Bladder, Overactive

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

YM178

Placebo

tolterodine

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Urge incontinence, YM178, Overactive Bladder, Urgency, Urinary incontinence, mirabegron, Micturition

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

YM178 group

Placebo group

tolterodine group

Arm Description

oral

Outcomes

Primary Outcome Measures

Change from baseline in the mean number of micturitions per 24 hours

Secondary Outcome Measures

Change from baseline in the mean number of urgency episodes per 24 hours

Change from baseline in the mean number of urinary incontinence episode per 24 hours

Change from baseline in the mean number of urge incontinence episodes per 24 hours

Change from baseline in the mean volume voided per micturition

Change from baseline in mean number of nocturia episodes

Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire

Full Information

NCT ID

NCT00966004

First Posted

August 24, 2009

Last Updated

February 14, 2017

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00966004

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Overactive

Keywords

Urge incontinence, YM178, Overactive Bladder, Urgency, Urinary incontinence, mirabegron, Micturition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YM178 group

Arm Type

Experimental

Arm Description

oral

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

oral

Arm Title

tolterodine group

Arm Type

Active Comparator

Arm Description

oral

Intervention Type

Drug

Intervention Name(s)

YM178

Other Intervention Name(s)

mirabegron

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

tolterodine

Other Intervention Name(s)

Detrol, Detrusitol

Intervention Description

oral

Primary Outcome Measure Information:

Title

Change from baseline in the mean number of micturitions per 24 hours

Time Frame