This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Procter and Gamble
Information provided by:
Novartis Identifier:
First received: September 12, 2005
Last updated: May 16, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Overactive Bladder Drug: Darifenacin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 400
Study Start Date: April 2005
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: 1
Drug: Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
Placebo Comparator: 2
Drug: Placebo
Placebo tablet once daily with sham titration


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00171184

United States, Texas
Scott Department of Urology Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Procter and Gamble
Study Chair: Novartis East Hanover NJ
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis Identifier: NCT00171184     History of Changes
Other Study ID Numbers: CDAR328A2409
Study First Received: September 12, 2005
Last Updated: May 16, 2017

Keywords provided by Novartis:
Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on September 21, 2017