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

NCT00171184 | Completed Phase 4

• 1 other identifier: CDAR328A2409
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Darifenacin

Drug: Darifenacin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Darifenacin DRUG

Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

Also known as: Enablex

1

Placebo DRUG

Placebo tablet once daily with sham titration

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead
• Procter and Gamble: collaborator

Study Sites (1)

Scott Department of Urology Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

darifenacin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis

  East Hanover NJ

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2005
• Study Completion: June 1, 2006
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

US (1)