Back to resultsA Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Primary Purpose
Overactive Bladder Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Darifenacin
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
Eligibility Criteria
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.
Sites / Locations
- Novartis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Darifenacin
Outcomes
Primary Outcome Measures
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
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),
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00170755
Brief Title
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Official Title
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
718 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Darifenacin
Intervention Type
Drug
Intervention Name(s)
Darifenacin
Other Intervention Name(s)
Enablex
Intervention Description
Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Long term efficacy on the symptoms of overactive bladder
Title
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),
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
East Hanover NJ
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936-108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18663723
Citation
Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R, Ebinger U. Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. Neurourol Urodyn. 2008;27(6):540-7. doi: 10.1002/nau.20620.
Results Reference
derived
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A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
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