A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK-0594 in Patients With Overactive Bladder - MK-0594 Overactive Bladder Dose-Ranging Study
- Conditions
- Overactive BladderMedDRA version: 8.0 Level: LLT Classification code 10059617
- Registration Number
- EUCTR2005-005606-23-DE
- Lead Sponsor
- Merck &Co.Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 530
Postmenopausal women or men aged 40 to 74 (inclusive). Up to 10% of patients will be male. Average of = 8 micturitions per day, average of = 1 urge incontinence episodes per day, and predominance of urge incontinence episodes over stress incontinence episodes on 2 pre-randomization voiding diaries.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
History of diabetes insipidus, uncotrolled hyperglycemia or hypercalcemia, lower urinary tract symptoms associated with benign prostatic hypertrophy, active or current UTI, surgery to correct prolapsed uterus or stress incontinence.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In patients with overactive bladder, to investigate a dose-related reduction in average number of daily micturitions after 8 weeks of treatment with MK-0594;Secondary Objective: In patients with overactive bladder: (1) to determine to tolerability of MK-0594 over 8 weeks of treatment. (2) To determine whether there is a lower incidence of dry mouth when treated with MK-0594 compared with tolterodine tartrate extended release.;Primary end point(s): Change from baseline in average daily micturitions.
- Secondary Outcome Measures
Name Time Method