drugset / Trial / NCT00409539
SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
Phase 2
Completed
550 enrolled
Sumitomo Pharma America, Inc.
ClinPhone, Inc. · collabCovance · collabDainippon Sumitomo Pharma America · collabICON Clinical Research · collabPPD Development, LP · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2006-12
- Primary completion
- 2008-06
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AFACIFENACIN | Small molecule | 20 mg | — |
| Subject | AFACIFENACIN | Small molecule | 40 mg | — |
| Subject | AFACIFENACIN | Small molecule | 80 mg | — |
| Subject | AFACIFENACIN | Small molecule | 120 mg | — |