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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01157377 | Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence | PHASE2 | COMPLETED | 160 | — | — | Oct 1, 2010 | May 1, 2013 | Mar 19, 2014 | 3 | United States, France +1 |
The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).
| Arm | Type | Description |
|---|---|---|
| AGN-214868 total dose 500 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 500 ng on Day 1. |
| AGN-214868 total dose 1000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1. |
| AGN-214868 total dose 2000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1. |
| AGN-214868 total dose 6000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1. |
| AGN-214868 total dose 18000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1. |
| AGN-214868 total dose 60000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1. |
| Placebo to AGN-214868 | PLACEBO_COMPARATOR | Placebo to AGN-214868 injected into the bladder on Day 1. |
| Name | Type | Description |
|---|---|---|
| AGN-214868 | DRUG | AGN-214868 injected into the bladder. |
| AGN-214868 placebo | DRUG | AGN-214868 placebo injected into the bladder. |
Inclusion Criteria: * If female, must be of nonreproductive potential * If male, must agree to use acceptable contraception * Symptoms of overactive bladder with urinary urgency incontinence * Inadequate response or limiting side effects with anticholinergics for the treatment of OAB Exclusion Cri...