Back to resultsEfficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Darifenacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population
Eligibility Criteria
Inclusion Criteria: Symptoms of OAB for at least six months prior to Visit 3 Symptoms of OAB during the 7 day diary period immediately preceding Visit 3: ≥ 1 UUIE on average per day and ≥ 10 episodes of micturition on average per day Exclusion Criteria: A total daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization Post-void residual (PVR) urinary volume > 100 ml Clinically significant stress urinary incontinence as determined by the investigator Clinically significant bladder outlet obstruction as determined by the investigator Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon. Other protocol inclusion / exclusion criteria may apply
Sites / Locations
- Scott Department of Urology Baylor College of Medicine
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 number of urge urinary incontinence episodes (UUIE) per week at week 12.
Secondary Outcome Measures
Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
Safety and tolerability.
Quality of life at week 6 and/or 12.
Full Information
NCT ID
NCT00171184
First Posted
September 12, 2005
Last Updated
May 16, 2017
Sponsor
Novartis
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT00171184
Brief Title
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Official Title
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Procter and Gamble
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged >Ý 65 years with OAB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (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 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet once daily with sham titration
Primary Outcome Measure Information:
Title
Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.
Secondary Outcome Measure Information:
Title
Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
Title
Safety and tolerability.
Title
Quality of life at week 6 and/or 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
Symptoms of OAB for at least six months prior to Visit 3
Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
≥ 1 UUIE on average per day and
≥ 10 episodes of micturition on average per day
Exclusion Criteria:
A total daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization
Post-void residual (PVR) urinary volume > 100 ml
Clinically significant stress urinary incontinence as determined by the investigator
Clinically significant bladder outlet obstruction as determined by the investigator
Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.
Other protocol 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
Scott Department of Urology Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
We'll reach out to this number within 24 hrs