Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 768
Healthy volunteers: no

Brief summary:
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Detailed description:
Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group.

The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.

Primary efficacy will be based on OAB-q symptom bother score.

Arms:
arm 1: Matching placebo tablet taken once daily arm 2: 5mg or 10mg tablet taken once daily

Interventions: intervention 1: Placebo intervention 2: Solifenacin Succinate
Intervention descriptions: intervention 1: Oral Administration intervention 2: Oral Administration

Protocol document: