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Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
This study has been completed.
First Received: June 30, 2005   Last Updated: January 23, 2008   History of Changes
Sponsor: Novartis
Collaborator: 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

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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination
Drug Information available for: Darifenacin Darifenacin hydrobromide
U.S. FDA Resources

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

  Hide Study Locations
Locations
United States, Alabama
Alabama Research Center
Birmingham, Alabama, United States, 35209
United States, Arizona
Quality of Life Medical & Research
Tucson, Arizona, United States, 85712
United States, California
San Diego Center for Urology Care
La Mesa, California, United States, 91942
Encompass Clinical Research
Spring Valley, California, United States, 91978
Western Clinical Research
Torrance, California, United States, 90505
UCLA - Urology Sciences Research Foundation
Culver City, California, United States, 90232
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
California Professional Research
Newport Beach, California, United States, 92660
Medical Center for Clinical Research
San Diego, California, United States, 92108
Private Practice
North Hollywood, California, United States, 91607
Orange County Urology Associates
Laguna Woods, California, United States, 92653
United States, Colorado
Western Urologic Associates
Wheat Ridge, Colorado, United States, 80033
Urology Research Options
Aurora, Colorado, United States, 80012
United States, Connecticut
Connecticut Clinical Research Center
Waterbury, Connecticut, United States, 06708
United States, Florida
Advance Research Institute
New Port Richey, Florida, United States, 34652
Winter Park Urology Associates
Orlando, Florida, United States, 32803
South Florida Medical Research
Aventura, Florida, United States, 33180
Florida Healthcare Research
Ocala, Florida, United States, 34474
United States, Georgia
Atlanta Medical Research Institute
Alpharetta, Georgia, United States, 30005
Shepard Center
Atlanta, Georgia, United States, 30309
United States, Illinois
RMD Clinical Research Institute
Melrose Park, Illinois, United States, 60160
Southern Illinois Clinical Research Center
O'Fallon, Illinois, United States, 62269
Springfield Clinic
Springfield, Illinois, United States, 62701
Deerpath Physicians Group
Gurnee, Illinois, United States, 60031
United States, Indiana
Urology of Indiana
Indianapolis, Indiana, United States, 46254
Metropolitan Urology
Jeffersonville, Indiana, United States, 47130
Welborn Clinic
Evansville, Indiana, United States, 47714
United States, Kansas
Hearthland Research Associates
Wichita, Kansas, United States, 67207
Cotton-O'Neil Clinic
Topeka, Kansas, United States, 66606
Pratt Internal Medicine Group
Pratt, Kansas, United States, 67124
Urologic Surgery Associates
Overland Park, Kansas, United States, 66215
United States, Minnesota
Adult and Pediatric Urology
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Mississippi Urology Clinical Research
Jackson, Mississippi, United States, 39202
United States, Missouri
Washing Univ School of Medicine - Urologic Research Center
St. Louis, Missouri, United States, 63141
PPS Clinical Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Women's Clinic of Lincoln
Lincoln, Nebraska, United States, 68510
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
Quality Clinical Research
Omaha, Nebraska, United States, 68131
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
Center for Urologic Care
Voorhees, New Jersey, United States, 08043
United States, New York
Hudson Valley Urology
Poughkeepsie, New York, United States, 12601
Central New York Clinical Research
Manlius, New York, United States, 13104
Jacobi Medical Center
Bronx, New York, United States, 10461
United States, North Carolina
Multi Specialty Research Associates of NC
Raleigh, North Carolina, United States, 27609
Piedmont Medical Research Associates
Winston Salem, North Carolina, United States, 27103
Northeast Urology Research
Concord, North Carolina, United States, 28025
United States, Oklahoma
Private Practice
Edmond, Oklahoma, United States, 73034
United States, Oregon
Portland Clinic
Portland, Oregon, United States, 97205
Williamette Women's Health
Tualatin, Oregon, United States, 97232
Southern Oregon Health and Wellness
Medford, Oregon, United States, 97504
United States, Pennsylvania
Univ. of Pittsburgh Medical Center- Dept of Urology
Pittsburg, Pennsylvania, United States, 15213
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
South Carolina Clinical Research Center
Columbia, South Carolina, United States, 29201
United States, Tennessee
Doctors for Women
Nashville, Tennessee, United States, 37203
United States, Texas
Medical Arts Clinic
Corsicana, Texas, United States, 75110
R/D Clinical Research
Lake Jackson, Texas, United States, 77566
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Radiant Research
Dallas, Texas, United States, 75231
Kelsey Seybold Research Foundation
Houston, Texas, United States, 77054
Advances in Health
Houston, Texas, United States, 77030
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
Progressive Clinical Research
Centerville, Utah, United States, 84014
Intermountain Clinical Research
Salt Lake City, Utah, United States, 84102
United States, Virginia
East Coast Clinical Research
Virginia Beach, Virginia, United States, 23454
Virginia Urology
Richmond, Virginia, United States, 23235
United States, Washington
Radiant Research
Lakewood, Washington, United States, 98499
Valley Women's Clinic
Renton, Washington, United States, 98055
Sponsors and Collaborators
Novartis
Procter and Gamble
Investigators
Study Director: Novartis Pharmaceuticals Corp. Novartis Pharmaceutical
  More Information

No publications provided

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

Keywords provided by Novartis:
OAB
Overactive Bladder
Bladder hyperactivity
 Urge Incontinence
Incontinence
Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Physiological Effects of Drugs
Urinary Bladder Diseases
Cholinergic Agents
 Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Darifenacin
Urinary Incontinence

ClinicalTrials.gov processed this record on November 27, 2009



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