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Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00366002
First received: August 17, 2006
Last updated: January 14, 2008
Last verified: January 2008
History of Changes
  Purpose

This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.


Condition Intervention Phase
Overactive Bladder (OAB)
 Drug: Darifenacin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).

Secondary Outcome Measures:
  • Patient's perception of outcome using the PPBC questionnaire at Week 7.
  • Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
  • Assessment of efficacy of darifenacin with respect to change from baseline in:
  • Number of micturitions per day at Weeks 7 and 13
  • Number of urgency episodes per day at Weeks 7 and 13
  • Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13
  • Assessment of safety and tolerability

Enrollment: 500
Study Start Date: June 2006
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: 1
Darifenacin
 Drug: Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex

  Eligibility

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

Inclusion Criteria:

  • • Symptoms of OAB for at least six months prior to randomization

    • ≥ 8 micturitions on average/24 hours
    • ≥ 1 urgency episodes on average/24 hours

    • with or without UUIE

      • Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.
      • Patients without prior darifenacin treatment

Exclusion Criteria:

  • • A mean daily urinary volume >3000 mL or a mean volume voided/micturition of >300 mL as verified in the micturition diary for two consecutive days prior to Baseline

    • Males with post-void residual (PVR) urinary volume >200 mL at Baseline
    • Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
    • Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator

Other protocol-defined inclusion / exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366002

  Show 82 Study Locations
Sponsors and Collaborators
Novartis
Procter and Gamble
Investigators
Study Chair: Novartis Pharmaceutical Corporation NPC
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00366002     History of Changes
Other Study ID Numbers: CDAR328A2404
Study First Received: August 17, 2006
Last Updated: January 14, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
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 23, 2013