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

Tracking Information

First Received Date ^ICMJE

August 17, 2006

Last Updated Date

January 14, 2008

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00366002 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Overactive Bladder (OAB)

Intervention ^ICMJE

Drug: Darifenacin

Study Arms / Comparison Groups

Experimental: Darifenacin

Publications *

Zinner N, Kobashi KC, Ebinger U, Viegas A, Egermark M, Quebe-Fehling E, Koochaki P. Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy. Int J Clin Pract. 2008 Nov;62(11):1664-74. Epub 2008 Sep 22.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00366002

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CDAR328A2404

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Procter and Gamble

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceutical Corporation

NPC

Information Provided By

Novartis

Verification Date

January 2008

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