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The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.
Full 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).
Enrollment
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Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
1,139 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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