Overactive Bladder (OAB)NCT01317810
A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication
An observational study of Overactive Bladder (OAB), run by Astellas Pharma Inc.
Trial summary
The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder (OAB)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with overactive bladder (OAB)
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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
The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.
Read the 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.
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Overactive Bladder (OAB), Observational, Registry
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Overactive Bladder (OAB) | Combination of new OAB subjects and existing subjects on OAB medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overactive bladder (OAB) medication/ treatment regimen
Measured: 6 months
Reason for change in OAB medication/treatment regimen
Measured: 6 months
Secondary outcomes (3)
Persistence of use of any OAB medication as reported by the Physician
Measured: 6 months
Change in OAB medication including discontinuation of OAB medication as reported by the Physician
Measured: 6 months
Subject reported efficacy
Measured by the Subject Survey Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
Why it stopped: Corporate decision not to initiate the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317810
- Sponsor's protocol ID
- 905-UC-060
- Status last verified
- Aug 2015
- First submitted
- 16 Mar 2011
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01317810
- Acronym / sponsor ID
- 905-UC-060
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Overactive Bladder (OAB), Observational, Registry
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Corporate decision not to initiate the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Overactive Bladder (OAB) | – | –Combination of new OAB subjects and existing subjects on OAB medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with overactive bladder (OAB)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in overactive bladder (OAB) medication/ treatment regimen
Time frame: 6 months
Reason for change in OAB medication/treatment regimen
Time frame: 6 months
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study director
Astellas Pharma Global Development, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder (OAB), run by Astellas Pharma Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overactive bladder (OAB) medication/ treatment regimen (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.