Overactive Bladder MedDRA version: 8.0 Level: LLT Classification code 10059617
Conditions
Sponsors
Merck Sharp and Dohme de España
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark, Germany, Spain, Sweden
Outcome results
None listed