Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00171184
• Date of registration: 12/09/2005
• Primary sponsor: Novartis
• Public title: Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
• Scientific title: Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
• Date of first enrolment: April 2005
• Target sample size: 400
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00171184
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Novartis
• Affiliation: East Hanover NJ

Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Drug: Darifenacin

Drug: Placebo

Primary Outcome(s)

Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.

Secondary Outcome(s)

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.

Quality of life at week 6 and/or 12.

Safety and tolerability.

Secondary ID(s)

CDAR328A2409

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Procter and Gamble