Back to resultsA 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Primary Purpose
Overactive Bladder Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Darifenacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin
Eligibility Criteria
Inclusion Criteria: Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2. 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 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Darifenacin
Placebo
Outcomes
Primary Outcome Measures
Change from baseline in warning time at week 12.
Secondary Outcome Measures
Change in warning time at weeks 2 & 6.
Change in frequency of urge incontinence episodes.
Change in frequency of micturitions.
Change in mean volume per void.
Change in frequency of urgency.
Safety and tolerability.
Quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171145
Brief Title
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Official Title
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.
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, warning time, darifenacin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Darifenacin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Darifenacin
Other Intervention Name(s)
Enablex
Intervention Description
Darifenacin 15 mg tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets once daily
Primary Outcome Measure Information:
Title
Change from baseline in warning time at week 12.
Secondary Outcome Measure Information:
Title
Change in warning time at weeks 2 & 6.
Title
Change in frequency of urge incontinence episodes.
Title
Change in frequency of micturitions.
Title
Change in mean volume per void.
Title
Change in frequency of urgency.
Title
Safety and tolerability.
Title
Quality of life.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
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
Learn more about this trial
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
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