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

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Darifenacin; Drug: Placebo

• Registration Number: NCT00171184
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Study Completion: 2006-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Darifenacin	Darifenacin
2	Placebo	Placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Scott Department of Urology Baylor College of Medicine; 🇺🇸 Houston, Texas, United States