Conditions: Overactive Bladder Syndrome (OABS)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 550
Healthy volunteers: no

Brief summary:
SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

Detailed description:
A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment period with patients randomized to receive 20 mg, 40 mg, 80 mg or 120 mg SMP 986 or placebo in a 1:1:1:1:1 ratio in parallel groups on an outpatient basis with study center visits.

Arms:
arm 1: Placebo run-in phase. 2 week duration. arm 2: To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). arm 3: 20mg dose of SMP-986 to be taken once daily for 8 week duration. arm 4: 40mg dose of SMP-986 to be taken for 8 week duration. arm 5: 80mg dose of SMP-986 to be taken for 8 week duration. arm 6: 120mg dose of SMP-986 to be taken for 8 week duration.

Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: SMP-986
Intervention descriptions: intervention 1: Placebo, 2 week duration. intervention 2: Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). intervention 3: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks

Protocol document: