NCT00409539

SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)

A 10-week Randomised, DB, PG, PC Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 (20, 40, 80 and 120 mg) Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder Syndrome (OABS)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo, 2 week duration.
DRUG	Placebo	Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
DRUG	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

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-06-01
• Completion: 2008-07-01
• First posted: 2006-12-11
• Last updated: 2014-12-10
• Results posted: 2014-12-10

Locations

69 sites across 9 countries: United States, Estonia, France, Germany, Latvia, Lithuania, Poland, Spain, United Kingdom