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A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication

This study has been withdrawn prior to enrollment.
(Corporate decision not to initiate the trial)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317810
First Posted: March 17, 2011
Last Update Posted: September 2, 2015
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.
Collaborator:
GlaxoSmithKline
Information provided by:
Astellas Pharma Inc
March 16, 2011
March 17, 2011
September 2, 2015
Not Provided
Not Provided
  • Change in overactive bladder (OAB) medication/ treatment regimen [ Time Frame: 6 months ]
  • Reason for change in OAB medication/treatment regimen [ Time Frame: 6 months ]
Change in overactive bladder (OAB) medication/ treatment regimen [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01317810 on ClinicalTrials.gov Archive Site
  • Persistence of use of any OAB medication as reported by the Physician [ Time Frame: 6 months ]
  • Change in OAB medication including discontinuation of OAB medication as reported by the Physician [ Time Frame: 6 months ]
  • Subject reported efficacy [ Time Frame: 6 months ]
    Measured by the Subject Survey Questionnaire
  • Reason for change in OAB medication/treatment regimen [ Time Frame: 6 months ]
  • Persistence of use of any OAB medication as reported by the Physician [ Time Frame: 6 months ]
  • Change in OAB medication including discontinuation of OAB medication as reported by the Physician [ Time Frame: 6 months ]
  • Subject reported efficacy [ Time Frame: 6 months ]
    Measured by the Subject Survey Questionnaire
Not Provided
Not Provided
 
A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication
A Phase 4, Observational, Non-interventional Study Measuring and Tracking Changes in Overactive Bladder Medication and/or Overactive Bladder Medication Dose in Subjects With Overactive Bladder
The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.
Subjects will complete a study specific survey questionnaire at Screening and the Month 1 through Month 6 visits. Subjects will be followed for 6 months.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects with overactive bladder (OAB)
Overactive Bladder (OAB)
Not Provided
Subjects with Overactive Bladder (OAB)
Combination of new OAB subjects and existing subjects on OAB medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

Inclusion Criteria:

  • Subject has overactive bladder as determined by their prescribing physician
  • Subject is currently receiving pharmacotherapy for overactive bladder
  • Subject is willing to comply with required protocol/study requirements

Exclusion Criteria:

  • Subject has a history of a clinically significant illness or medical condition prior to screening that would preclude participation in the study
  • Male subjects with Lower Urinary Tract Symptoms (LUTS) or Bladder Outlet Obstruction (BOO)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01317810
905-UC-060
No
Not Provided
Not Provided
Clinical Trials Registry, Astellas Pharma US, Inc
Astellas Pharma Inc
GlaxoSmithKline
Study Director: Use Central Contact Astellas Pharma Global Development, Inc.
Astellas Pharma Inc
August 2015