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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
550
Placebo, 2 week duration.
Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
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
Visions Clinical Research
Tuscon, Arizona, United States
Peninsula Urology Center
Atherton, California, United States
San Bernadino Urological Association Medical Group
San Bernadino, California, United States
9040 Friars Road
San Diego, California, United States
South Florida Medical Research
Aventura, Florida, United States
Change From Baseline to Week 8 in the Number of Voids/24 Hours
Time frame: 8 Weeks
To Assess the Safety and Tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d) Following 8-weeks of Treatment in Patients With Over Active Bladder Syndrome
Treatment emergent adverse event summary
Time frame: 8 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Visions Clinical Research
Boynton Beach, Florida, United States
Florida Healthcare Research
Ocala, Florida, United States
Southern Research Group, Centre Point Boulevard
Tallahassee, Florida, United States
Atlanta Medical Research
Alpharetta, Georgia, United States
Urological Surgeons of IL
Kankakee, Illinois, United States
...and 59 more locations