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

Urinary Bladder, Overactive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966004
• Other study ID #: 178-CL-048
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2009
• Last updated: February 14, 2017
• Start date: July 2009
• Est. completion date: February 2010

Study information

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

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1139
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• YM178
oral
• Placebo
oral
• tolterodine
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the mean number of micturitions per 24 hours		Within a 12-week treatment period
Secondary	Change from baseline in the mean number of urgency episodes per 24 hours		Within a 12-week treatment period
Secondary	Change from baseline in the mean number of urinary incontinence episode per 24 hours		Within a 12-week treatment period
Secondary	Change from baseline in the mean number of urge incontinence episodes per 24 hours		Within a 12-week treatment period
Secondary	Change from baseline in the mean volume voided per micturition		Within a 12-week treatment period
Secondary	Change from baseline in mean number of nocturia episodes		Within a 12-week treatment period
Secondary	Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire		Within a 12-week treatment period

External Links

•   Link to results on Astellas Clinical Study Results website