This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder

NCT00943735

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female outpatients >=18 years old

- Eligible for receiving Toviaz 4mg or 8mg QD treatment based on the approved US label.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Female subjects who are pregnant, lactating, or who are intending to become pregnant
within 28 days after the completion of the study (use of contraceptives is not
required to participate in the study)


- Have participated in any other studies involving study drugs within 30 days prior to
entry in the study


- Subjects who have previously taken fesoterodine.

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Advanced Information
Descriptive Information
Brief Title This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder
Official Title A 13-Week, Single-Arm, Open-Label, Multicenter Study To Evaluate Refill Adherence And Satisfaction With Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder.
Brief Summary The primary objective of the study is to assess the level of medication adherence observed among subjects receiving a specific combination of education and support materials (YourWay plan) along with a prescription for fesoterodine.
Detailed Description This is a non-interventional, observational study. Study investigators will recruit symptomatic, fesoterodine-naïve subjects when they present with OAB symptoms during regularly-scheduled physician visits fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits
Condition Overactive Bladder
Intervention
  • Drug: Fesoterodine
    Fesoterodine 4 mg and 8 mg QD
  • Behavioral: Your Way
    early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB
Study Groups/Cohorts Fesoterodine arm
subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy
Interventions:
  • Drug: Fesoterodine
  • Behavioral: Your Way
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 21, 2011)
774
Original Estimated Enrollment
 (submitted: July 21, 2009)
640
Actual Study Completion Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female outpatients >=18 years old
  • Eligible for receiving Toviaz 4mg or 8mg QD treatment based on the approved US label.

Exclusion Criteria:

  • Female subjects who are pregnant, lactating, or who are intending to become pregnant within 28 days after the completion of the study (use of contraceptives is not required to participate in the study)
  • Have participated in any other studies involving study drugs within 30 days prior to entry in the study
  • Subjects who have previously taken fesoterodine.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00943735
Other Study ID Numbers A0221078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018