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

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00127270
First received: June 30, 2005
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder

Resource links provided by NLM:

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
Experimental: 1
Darifenacin
 Drug: Darifenacin
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
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

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00127270     History of Changes
Other Study ID Numbers: CDAR328AUS01
Study First Received: June 30, 2005
Last Updated: January 23, 2008
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 Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Darifenacin
 Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013