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This study has been withdrawn prior to enrollment.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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014