Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy|
- Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
- Patient's perception of outcome using the PPBC questionnaire at Week 7.
- Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
- Assessment of efficacy of darifenacin with respect to change from baseline in:
- Number of micturitions per day at Weeks 7 and 13
- Number of urgency episodes per day at Weeks 7 and 13
- Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13
- Assessment of safety and tolerability
|Study Start Date:||June 2006|
|Study Completion Date:||September 2007|
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366002
Show 82 Study Locations
|Study Chair:||Novartis Pharmaceutical Corporation||NPC|