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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This study has been withdrawn prior to enrollment.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
  Purpose

The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.


Condition
Overactive Bladder (OAB)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 35
Groups/Cohorts
Subjects with Overactive Bladder (OAB)
Combination of new OAB subjects and existing subjects on OAB medication

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with overactive bladder (OAB)

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317810

Sponsors and Collaborators
Astellas Pharma Inc
GlaxoSmithKline
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development, Inc.
  More Information

No publications provided

Responsible Party: Clinical Trials Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT01317810     History of Changes
Other Study ID Numbers: 905-UC-060
Study First Received: March 16, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Overactive Bladder (OAB)
Observational
Registry

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013