The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.
This is a multinational, multicenter, double-blind, double-dummy, randomized, parallel group, placebo and active controlled phase II proof-of concept study. Patients are enrolled into a single-blind, 2-week placebo run in period after which they are randomized to 4 weeks of double-blind treatment with YM178 (low dose and high dose), placebo or tolterodine. Subsequently patients will be followed for an additional 2 weeks with single-blind placebo treatment. There are 6 visits in total: visit 1 at enrolment, visit 2 (baseline) after the 2-week placebo run-in, visits 3, 4 and 5 after 1, 2 and 4 weeks of double-blind treatment respectively, and visit 6 after a 2-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
Site: 12
Brussels, Belgium
Change from baseline in mean number of micturitions per 24 hours
Time frame: Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of urgency episodes/24 hours
Time frame: Baseline and 4 weeks (end of treatment)
Change from baseline in mean volume voided per micturition
Time frame: Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of urge incontinence episodes/24 hours
Time frame: Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of incontinence episodes/24 hours
Time frame: Baseline and 4 weeks (end of treatment)
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Site: 13
Edegem, Belgium
Site: 11
Ghent, Belgium
Site: 10
Leuven, Belgium
Site: 25
Mělník, Czechia
Site: 22
Prague, Czechia
Site: 24
Prague, Czechia
Site: 20
Prague, Czechia
Site: 21
Ústí nad Labem, Czechia
Site: 23
Ústí nad Labem, Czechia
...and 20 more locations