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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This study has been withdrawn prior to enrollment.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:
Collaborator:
GlaxoSmithKline
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01317810
First received: March 16, 2011
Last updated: June 22, 2011
Last verified: June 2011
History of Changes

March 16, 2011
June 22, 2011
Not Provided
Not Provided
  • Change in overactive bladder (OAB) medication/ treatment regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reason for change in OAB medication/treatment regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
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 ] [ Designated as safety issue: No ]
  • Change in OAB medication including discontinuation of OAB medication as reported by the Physician [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Subject reported efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by the Subject Survey Questionnaire
  • Reason for change in OAB medication/treatment regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Persistence of use of any OAB medication as reported by the Physician [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in OAB medication including discontinuation of OAB medication as reported by the Physician [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Subject reported efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
35
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01317810
905-UC-060
No
Clinical Trials Registry, Astellas Pharma US, Inc
Astellas Pharma Inc
GlaxoSmithKline
Study Director: Use Central Contact Astellas Pharma Global Development, Inc.
Astellas Pharma Inc
June 2011

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