Overactive BladderNCT01898624
Specified Drug Use-results Survey of Betanis Tablets
An observational study of Overactive Bladder, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- mirabegron
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 7 sitesJapan
- Study dates
- 4 Dec 2012to 10 Jan 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: OAB patients with coexisting glaucoma treated with mirabegron
Who may be able to join
- diagnosed as OAB and treated with mirabegron
- diagnosed as glaucoma (including normal tension glaucoma)
- having intraocular pressure measurement conducted more than twice within six months before the start of the mirabegron treatment
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Chugoku
Study site
Kansai
Study site
Kanto
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: Specified Drug Use-results Survey of Betanis Tablets in OAB Patients With Coexisting Glaucoma
To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.
- Conditions
- Overactive Bladder
- Being tested
- mirabegron
- Keywords
- mirabegron, Overactive Bladder, Betanis®, glaucoma
- Medical subject headings
- Urinary Bladder, Overactive, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called Betanis, YM178
oral
| Study group | Role | What they receive |
|---|---|---|
| Betanis group | mirabegron treated group Receives: Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma
Measured: 12 weeks
Secondary outcomes (1)
Changes in OABSS (Over Active Bladder Symptoms Score)
OABSS is judged by investigator
Measured: Baseline and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study start4 Dec 2012
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898624
- Sponsor's protocol ID
- BE0004
- Status last verified
- Feb 2018
- First submitted
- 10 Jul 2013
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specified Drug Use-results Survey of Betanis Tablets in OAB Patients With Coexisting Glaucoma
- ClinicalTrials.gov ID
- NCT01898624
- Acronym / sponsor ID
- BE0004
- Conditions
- Overactive Bladder
- Keywords
- mirabegron, Overactive Bladder, Betanis®, glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 12 Jul 2013 (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.
To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Betanis group | – | Drug: mirabegronmirabegron treated group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- OAB patients with coexisting glaucoma treated with mirabegron
Key inclusion criteria (3 listed)
- diagnosed as OAB and treated with mirabegron
- diagnosed as glaucoma (including normal tension glaucoma)
- having intraocular pressure measurement conducted more than twice within six months before the start of the mirabegron treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegronAlso: Betanis, YM178oral | Drug | Betanis group |
Primary outcome
The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma
Time frame: 12 weeks
1 secondary outcome
Changes in OABSS (Over Active Bladder Symptoms Score)
Time frame: Baseline and 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Overactive Bladder
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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.
Central Contact study director
Astellas Pharma Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Astellas Pharma Inc at 7 sites in Japan.
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 0 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: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma (time frame: 12 weeks). 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 5 Feb 2018.