Overactive BladderNCT01919047
Drug Use-Results Survey of Betanis Tablets in Japan
An observational study of Overactive Bladder, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
This study is to determine the following information. 1. The occurrence of adverse drug reactions in clinical settings. 2. Factors potentially impacting safety, effectiveness, and other aspects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Betanis
- Type of treatment
- Pill or oral medicine
- How many people
- 10,711 participants
- Where
- 8 sitesJapan
- Study dates
- Apr 2012to Jul 2014
- 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: Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.
Who may be able to join
- Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: Drug Use-Results Survey of Betanis Tablets 25 and 50 mg
This study is to determine the following information.
- The occurrence of adverse drug reactions in clinical settings.
- Factors potentially impacting safety, effectiveness, and other aspects.
Read the detailed description
This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron):
- The occurrence of adverse drug reactions in clinical settings.
- Factors potentially impacting safety, effectiveness, and other aspects.
Items of Particular Interest:
- Safety and effectiveness in patients with hepatic impairment and patients with renal impairment.
- Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs).
- The occurrence of cardiovascular adverse events.
- The occurrence of adverse events related to increased intraocular pressure.
- The occurrence of urinary retention
- Conditions
- Overactive Bladder
- Being tested
- Betanis
- Keywords
- overactive bladder, mirabegron, occurrence of adverse events, Overactive Bladder Symptom Score
- 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.
BetanisDrug
Also called Mirabegron, YM178
Oral
| Study group | Role | What they receive |
|---|---|---|
| Betanis group | Patients receiving Betanis for Overactive Bladder Receives: Drug: Betanis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events and adverse drug reactions
Measured: For 12 weeks
Secondary outcomes (2)
Changes in OABSS (overactive bladder symptom score)
Measured: baseline and at 12 weeks (or last observation period)
Items of particular interest
Measured: baseline and at 12 weeks (or last observation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionJul 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919047
- Sponsor's protocol ID
- BE0001
- Status last verified
- Oct 2015
- First submitted
- 6 Aug 2013
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use-Results Survey of Betanis Tablets 25 and 50 mg
- ClinicalTrials.gov ID
- NCT01919047
- Acronym / sponsor ID
- BE0001
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, mirabegron, occurrence of adverse events, Overactive Bladder Symptom Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,711 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Aug 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.
This study is to determine the following information.
- The occurrence of adverse drug reactions in clinical settings.
- Factors potentially impacting safety, effectiveness, and other aspects.
Detailed description
This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron):
- The occurrence of adverse drug reactions in clinical settings.
- Factors potentially impacting safety, effectiveness, and other aspects.
Items of Particular Interest:
- Safety and effectiveness in patients with hepatic impairment and patients with renal impairment.
- Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs).
- The occurrence of cardiovascular adverse events.
- The occurrence of adverse events related to increased intraocular pressure.
- The occurrence of urinary retention
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Betanis group | – | Drug: BetanisPatients receiving Betanis for Overactive Bladder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.
Key inclusion criteria (1 listed)
- Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.
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 |
|---|---|---|
| BetanisAlso: Mirabegron, YM178Oral | Drug | Betanis group |
Primary outcome
Occurrence of adverse events and adverse drug reactions
Time frame: For 12 weeks
2 secondary outcomes
Changes in OABSS (overactive bladder symptom score)
Time frame: baseline and at 12 weeks (or last observation period)
Items of particular interest
Time frame: baseline and at 12 weeks (or last observation period)
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 Oct 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.
Central Contact study chair
Astellas Pharma Inc
8 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 8 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 1 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 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Occurrence of adverse events and adverse drug reactions (time frame: For 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 Oct 2015.