Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
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|ClinicalTrials.gov Identifier: NCT00366002|
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : January 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder (OAB)||Drug: Darifenacin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2006|
|Actual 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366002
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|Study Chair:||Novartis Pharmaceutical Corporation||NPC|