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

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

January 23, 2008

Start Date ^ICMJE

May 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change from baseline in within-patient average number of micturitions per day measured at Week 12

Change History

Complete list of historical versions of study NCT00127270 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Change from baseline in within-patient average number of micturitions per day measured at Week 2 and Week 6
Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal voids per day measured at Weeks 2, 6, and 12 (averaged within-patient over each diary recording period)
Quality of Life assessment using the OAB-q (baseline, Week 6, and Week 12), OAB-SAT-q (Week 12), and modified Female Sexual Function Index (mFSFI) (baseline and Week 12)

Descriptive Information

Brief Title ^ICMJE

Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder

Official Title ^ICMJE

Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Urinary Incontinence

Intervention ^ICMJE

Drug: Darifenacin
Behavioral: Behavioral therapy

Study Arms / Comparison Groups

Experimental: Darifenacin
Other: Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

395

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00127270

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CDAR328AUS01

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Procter and Gamble

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals Corp.

Novartis Pharmaceutical

Information Provided By

Novartis

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP