A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

This study has been completed.

First Received: September 9, 2005 Last Updated: January 15, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170755

Purpose

This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Condition	Intervention	Phase
Overactive Bladder Syndrome	Drug: Darifenacin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Resource links provided by NLM:

Drug Information available for: Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.

Secondary Outcome Measures:

Long term efficacy on the symptoms of overactive bladder
King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),

Enrollment:	718
Study Start Date:	April 2002
Study Completion Date:	January 2005

Arms	Assigned Interventions
1: Experimental Darifenacin	Drug: Darifenacin Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily

Eligibility

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

Criteria

Inclusion Criteria:

Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
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: NCT00170755

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

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R, Ebinger U. Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. Neurourol Urodyn. 2008;27(6):540-7.

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328A2301
Study First Received:	September 9, 2005
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00170755 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele
Cholinergic Antagonists

Darifenacin
Urologic Diseases
Urinary Bladder Diseases
Urinary Incontinence
Cholinergic Agents

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Urinary Bladder Diseases
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Pathologic Processes
Urologic Diseases
Darifenacin
Syndrome

ClinicalTrials.gov processed this record on July 02, 2009