A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder. - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171145

Purpose

This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.

Condition	Intervention	Phase
Overactive Bladder Syndrome	Drug: Darifenacin Drug: Placebo	Phase III

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, Efficacy Study
Official Title:	A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in warning time at week 12.

Secondary Outcome Measures:

Change in warning time at weeks 2 & 6.
Change in frequency of urge incontinence episodes.
Change in frequency of micturitions.
Change in mean volume per void.
Change in frequency of urgency.
Safety and tolerability.
Quality of life.

Enrollment:	445
Study Start Date:	April 2004
Study Completion Date:	December 2004

Arms	Assigned Interventions
1: Experimental Darifenacin	Drug: Darifenacin Darifenacin 15 mg tablets once daily
2: Placebo Comparator Placebo	Drug: Placebo Placebo tablets once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion Criteria:

Patients in whom the use of anticholinergic drugs was contraindicated
Evidence of severe liver disease
Patients with other clinically significant urinary or gynecological conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171145

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936-108

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

East Hanover NJ

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328A2401
Study First Received:	September 12, 2005
Last Updated:	January 18, 2008
ClinicalTrials.gov Identifier:	NCT00171145
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Darifenacin

Urologic Diseases
Urinary Bladder Diseases
Urinary Incontinence

Additional relevant MeSH terms:

Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists
Syndrome
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009