Urinary Bladder, OveractivePhase 3NCT00840645
A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients
A Phase 3 study testing YM178 in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- YM178
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesJapan
- Study dates
- Dec 2008to Mar 2010
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has symptoms of overactive bladder for >= 24 wks
- Subject experiences frequency of micturition at average >= 8 times per 24 hrs confirmed by the 3-day patient diary
Who cannot join
- Subject is breastfeeding, pregnant, or intends to become pregnant during the study
- Subject obviously has stress incontinence
- Subject has an indwelling catheter or practices intermittent self catheterization
- Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc
- Subject has an average total daily urine volume > 3000 mL confirmed by patient diary
- Subject has uncontrollable hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder
The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- YM178
- Keywords
- YM178, Urinary Bladder, Overactive, Mirabegron
- 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.
YM178Drug
Also called Mirabegron
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1. YM178 | Experimental | Not described Receives: Drug: YM178 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs, AEs, lab tests, ECG, post-void residual volume
Measured: 52 weeks
Secondary outcomes (5)
Changes from baseline in the mean number of micturitions/24hrs
Measured: 52 weeks
Changes from baseline in the mean number of urinary urgencies/24 hrs
Measured: 52 weeks
Changes from baseline in the mean number of incontinence episodes/24 hrs
Measured: 52 weeks
Changes from baseline in the mean number of urge incontinence episodes/24 hrs
Measured: 52 weeks
Changes from baseline in the mean number of nocturnal urinations
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840645
- Sponsor's protocol ID
- 178-CL-051
- Status last verified
- Jan 2016
- First submitted
- 8 Feb 2009
- Last updated
- 5 Jan 2016
- 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 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00840645
- Acronym / sponsor ID
- 178-CL-051
- Conditions
- Urinary Bladder, Overactive
- Keywords
- YM178, Urinary Bladder, Overactive, Mirabegron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Feb 2009 (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 study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. YM178 | Experimental | Drug: YM178 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has symptoms of overactive bladder for >= 24 wks
- Subject experiences frequency of micturition at average >= 8 times per 24 hrs confirmed by the 3-day patient diary
Key exclusion criteria (6 listed)
- Subject is breastfeeding, pregnant, or intends to become pregnant during the study
- Subject obviously has stress incontinence
- Subject has an indwelling catheter or practices intermittent self catheterization
- Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc
- Subject has an average total daily urine volume > 3000 mL confirmed by patient diary
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 |
|---|---|---|
| YM178Also: MirabegronOral | Drug | 1. YM178 |
Primary outcome
Vital signs, AEs, lab tests, ECG, post-void residual volume
Time frame: 52 weeks
5 secondary outcomes
Changes from baseline in the mean number of micturitions/24hrs
Time frame: 52 weeks
Changes from baseline in the mean number of urinary urgencies/24 hrs
Time frame: 52 weeks
Changes from baseline in the mean number of incontinence episodes/24 hrs
Time frame: 52 weeks
Changes from baseline in the mean number of urge incontinence episodes/24 hrs
Time frame: 52 weeks
Changes from baseline in the mean number of nocturnal urinations
Time frame: 52 weeks
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 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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 chair
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YM178 in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 2 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 2 inclusion and 6 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vital signs, AEs, lab tests, ECG, post-void residual volume (time frame: 52 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 Jan 2016.