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OpenTrials
Completed

NCT Number: NCT00366002

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

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.

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Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Site, Birmingham, Alabama, United States

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darifenacin

Drug

Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

Other names: Enablex

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Procter and Gamble

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Aug 18, 2006
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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