Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: Darifenacin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: East Hanover NJ
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.
Clinical Details
Official title: Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.
Secondary outcome: 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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Scott Department of Urology Baylor College of Medicine, Houston, Texas 77030, United States
Additional Information
Novartis patient recruitment website
Starting date: April 2005
Ending date: June 2006
Last updated: January 14, 2008
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