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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127270
First Posted: August 5, 2005
Last Update Posted: January 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Procter and Gamble
Information provided by:
Novartis
June 30, 2005
August 5, 2005
January 24, 2008
May 2005
Not Provided
Change from baseline in average number of urinations per patient per day at Week 12
Not Provided
Complete list of historical versions of study NCT00127270 on ClinicalTrials.gov Archive Site
  • 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)
Not Provided
Not Provided
Not Provided
 
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Urinary Incontinence
  • Drug: Darifenacin
    Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
    Other Name: Enablex
  • Drug: Darifenacin
    Darifenacin tablets 7,5 mg or 15 mg once daily
  • Behavioral: Behavioral therapy
    Behavioral Modification Programme for symptoms of overactive bladder
  • Experimental: 1
    Darifenacin
    Intervention: Drug: Darifenacin
  • 2
    Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
    Interventions:
    • Drug: Darifenacin
    • Behavioral: Behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
February 2006
Not Provided

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00127270
CDAR328AUS01
Not Provided
Not Provided
Not Provided
External Affairs, Novartis
Novartis
Procter and Gamble
Study Director: Novartis Pharmaceuticals Corp. Novartis Pharmaceutical
Novartis
January 2008

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