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

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

Drug Information available for: Darifenacin Darifenacin hydrobromide

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

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),

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:

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

Publications indexed to this study:

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328A2301
Study First Received:	September 9, 2005
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00170755
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:

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