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OpenTrials
Completed

NCT Number: NCT00171184

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scott Department of Urology Baylor College of Medicine

Houston, Texas, 77030, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darifenacin

Drug

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

Other names: Enablex

Placebo

Drug

Placebo tablet once daily with sham titration

Primary outcomes

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

Secondary outcomes

  1. 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.

  2. Safety and tolerability.

  3. Quality of life at week 6 and/or 12.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Procter and Gamble

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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