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

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. Identifier: NCT00366002
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : January 15, 2008
Procter and Gamble
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Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder (OAB) Drug: Darifenacin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00366002

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Sponsors and Collaborators
Procter and Gamble
Study Chair: Novartis Pharmaceutical Corporation NPC

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00366002     History of Changes
Other Study ID Numbers: CDAR328A2404
First Posted: August 18, 2006    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents