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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00966004
• Date of registration: 24/08/2009
• Primary sponsor: Astellas Pharma Inc
• Public title: A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder
• Scientific title: Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder
• Date of first enrolment: July 2009
• Target sample size: 1139
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00966004
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Use Central Contact
• Affiliation: Astellas Pharma Inc

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Urinary Bladder, Overactive

Intervention(s)

Drug: Placebo

Drug: tolterodine

Drug: YM178

Primary Outcome(s)

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

Secondary Outcome(s)

Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire [Time Frame: Within a 12-week treatment period]

Change from baseline in mean number of nocturia episodes [Time Frame: Within a 12-week treatment period]

Change from baseline in the mean number of urge incontinence episodes per 24 hours [Time Frame: Within a 12-week treatment period]

Change from baseline in the mean number of urgency episodes per 24 hours [Time Frame: Within a 12-week treatment period]

Change from baseline in the mean number of urinary incontinence episode per 24 hours [Time Frame: Within a 12-week treatment period]

Change from baseline in the mean volume voided per micturition [Time Frame: Within a 12-week treatment period]

Secondary ID(s)

178-CL-048

Source(s) of Monetary Support

Please refer to primary and secondary sponsors