Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder - Full Text View

Sponsors and Collaborators:	Novartis Procter and Gamble
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00127270

Purpose

This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.

Condition	Intervention	Phase
Urinary Incontinence	Drug: Darifenacin Behavioral: Behavioral therapy	Phase IV

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in average number of urinations per patient per day at Week 12

Secondary Outcome Measures:

Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6
Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12
Quality of Life (baseline, Week 6, Week 12)

Enrollment:	395
Study Start Date:	May 2005
Study Completion Date:	February 2006

Arms	Assigned Interventions
1: Experimental Darifenacin	Drug: Darifenacin Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
2 Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder	Drug: Darifenacin Darifenacin tablets 7,5 mg or 15 mg once daily Behavioral: Behavioral therapy Behavioral Modification Programme for symptoms of overactive bladder

Eligibility

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

Criteria

Inclusion Criteria:

Symptoms of overactive bladder
Capable of independent toileting and completing a micturition diary
Able to comprehend English and follow study procedures and instructions

Exclusion Criteria:

Post void residual > 100ml/sec
Urine flow rate (Qmax) <10ml/sec for males only

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127270

Show 67 Study Locations

Sponsors and Collaborators

Novartis

Procter and Gamble

Investigators

Study Director:

Novartis Pharmaceuticals Corp.

Novartis Pharmaceutical

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328AUS01
Study First Received:	June 30, 2005
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00127270
Health Authority:	United States: Institutional Review Board

Keywords provided by Novartis:

OAB
Overactive Bladder
Bladder hyperactivity

Urge Incontinence
Incontinence
Bladder

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Darifenacin
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Hyperkinesis
Urinary Incontinence
Urinary Incontinence, Urge

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