Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00409539 | SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS) | PHASE2 | COMPLETED | 550 | — | — | Dec 1, 2006 | Jul 1, 2008 | Dec 10, 2014 | 69 | United States, Estonia +7 |
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | Placebo run-in phase. 2 week duration. |
| 2 | PLACEBO_COMPARATOR | To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). |
| 3 | EXPERIMENTAL | 20mg dose of SMP-986 to be taken once daily for 8 week duration. |
| 4 | EXPERIMENTAL | 40mg dose of SMP-986 to be taken for 8 week duration. |
| 5 | EXPERIMENTAL | 80mg dose of SMP-986 to be taken for 8 week duration. |
| 6 | EXPERIMENTAL | 120mg dose of SMP-986 to be taken for 8 week duration. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo, 2 week duration. |
| SMP-986 | DRUG | 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 |
Inclusion Criteria: Main Inclusion Criteria: * Males, or females who are not of child-bearing potential * Aged 20-80 years (inclusive) with a diagnosis of OABS based on symptomatic reporting over a period of 6 months (micturition frequency, and urgency with or without incontinence) prior to screen...