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NCT00171184 Clinical Trial

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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171184
Other study ID # CDAR328A2409
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated May 16, 2017
Start date April 2005
Est. completion date June 2006

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
• Placebo
Placebo tablet once daily with sham titration

Locations
Country Name City State
United States Scott Department of Urology Baylor College of Medicine Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
Novartis Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.
Secondary 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.
Secondary Safety and tolerability.
Secondary Quality of life at week 6 and/or 12.
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