A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
- Registration Number
- NCT00170755
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 718
Inclusion Criteria
- Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
- Patients capable of independent toileting and able of independently completing the patient diary.
Exclusion Criteria
- Patients in whom the use of anticholinergic drugs was contraindicated
- Evidence of severe liver disease
- Patients with other clinically significant urinary or gynecological conditions
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Darifenacin Darifenacin
- Primary Outcome Measures
Name Time Method Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.
- Secondary Outcome Measures
Name Time Method Long term efficacy on the symptoms of overactive bladder King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States