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

Sponsors and Collaborators:	Novartis Procter and Gamble
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171184

Purpose

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 IV

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

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

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171184

Locations

United States, Texas
Scott Department of Urology Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Novartis

Procter and Gamble

Investigators

Study Chair:

Novartis

East Hanover NJ

More Information

Novartis patient recruitment website This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328A2409
Study First Received:	September 12, 2005
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00171184
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

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

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele

Darifenacin
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009