Urinary Bladder, OveractivePhase 3NCT01043666
A Study of YM178 in Subjects With Symptoms of Overactive Bladder
A Phase 3 study testing YM178 and tolterodine ER in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 35 sites in 4 countries.
Trial summary
This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- YM178 and tolterodine ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,126 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 21 Dec 2009to 16 Sep 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with symptoms of overactive bladder for at least 12 weeks before the study
- Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
- Subject with an average frequency of micturition of 8 or more times per 24-hour period
- Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
- Subject having provided written informed consent by him/herself
Who cannot join
- Subject having stress urinary incontinence as a predominant symptom
- Subject with transient symptoms suspected for overactive bladder
- Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
- Subject complicated with bladder tumor/prostatic tumor or with the historical condition
- Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease
- Subject with indwelling catheter or practicing intermittent self-catheterization
Show all 10Show fewer
- Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
- Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
- Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg)
- Subject with a pulse rate >= 110bpm or <50 bpm
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
China11 sites
Study site
Beijing
Study site
Dalian
Study site
Fuzhou
Study site
Guangzhou
Study site
Hangzhou
Study site
Hubei
Study site
Hunan
Study site
Jiangsu
Study site
Liaoning
Study site
Nanjing
Study site
Shanghai
South Korea11 sites
Study site
Busan
Study site
Chungcheong Namdo
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Gyeonggi-do
Study site
Incheon
Study site
Jeollabuk
Study site
Jeollanam
Study site
Kyonggi
Study site
Seoul
Taiwan7 sites
Study site
Chiayi City
Study site
Hualien City
Study site
Kaohsiung City
Study site
Taichung
Study site
Tainan
Study site
Taipei
Study site
Taoyuan
India6 sites
Study site
Ahmedabad
Study site
Gūrgaon
Study site
Jaipur
Study site
Lucknow
Study site
New Delhi
Study site
Pune
About this study
Official title: Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder
This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- YM178, Placebo, tolterodine ER
- Keywords
- Micturition, YM178, Urinary incontinence, Frequency, Overactive Bladder, Urgency, Urinary urge incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM178Drug
Also called mirabegron
oral
PlaceboDrug
oral
tolterodine ERDrug
Also called Detrusitol SR
oral
| Study group | Role | What they receive |
|---|---|---|
| YM178 group | Experimental | oral Receives: Drug: YM178 |
| placebo group | Placebo comparator | oral Receives: Drug: Placebo |
| tolterodine ER group | Experimental | oral Receives: Drug: tolterodine ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean number of micturitions per 24 hrs
Measured: Within a 12-week treatment period
Secondary outcomes (6)
Change in mean number of urgency episodes per 24 hrs
Measured: Within a 12-week treatment period
Change in mean number of urinary incontinence episodes per 24 hrs
Measured: Within a 12-week treatment period
Change in mean number of urge incontinence episodes per 24 hrs
Measured: Within a 12-week treatment period
Change in mean volume voided per micturition
Measured: Within a 12-week treatment period
Change in mean number of nocturia episodes
Measured: Within a 12-week treatment period
Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume
Measured: During 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study start21 Dec 2009
- Primary completion16 Sep 2011
- Study completion16 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,126 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
- NCT01043666
- Sponsor's protocol ID
- 178-CL-090
- Status last verified
- Oct 2024
- First submitted
- 5 Jan 2010
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder
- ClinicalTrials.gov ID
- NCT01043666
- Acronym / sponsor ID
- 178-CL-090
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Micturition, YM178, Urinary incontinence, Frequency, Overactive Bladder, Urgency, Urinary urge incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,126 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2009 (actual)
- Primary completion
- 16 Sep 2011 (actual)
- Study completion
- 16 Sep 2011 (actual)
- First posted
- 7 Jan 2010 (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 assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YM178 group | Experimental | Drug: YM178oral |
| placebo group | Placebo comparator | Drug: Placebooral |
| tolterodine ER group | Experimental | Drug: tolterodine ERoral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with symptoms of overactive bladder for at least 12 weeks before the study
- Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
- Subject with an average frequency of micturition of 8 or more times per 24-hour period
- Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
- Subject having provided written informed consent by him/herself
Key exclusion criteria (10 listed)
- Subject having stress urinary incontinence as a predominant symptom
- Subject with transient symptoms suspected for overactive bladder
- Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
- Subject complicated with bladder tumor/prostatic tumor or with the historical condition
- Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease
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 | YM178 group |
| Placebooral | Drug | placebo group |
| tolterodine ERAlso: Detrusitol SRoral | Drug | tolterodine ER group |
Primary outcome
Change in mean number of micturitions per 24 hrs
Time frame: Within a 12-week treatment period
6 secondary outcomes
Change in mean number of urgency episodes per 24 hrs
Time frame: Within a 12-week treatment period
Change in mean number of urinary incontinence episodes per 24 hrs
Time frame: Within a 12-week treatment period
Change in mean number of urge incontinence episodes per 24 hrs
Time frame: Within a 12-week treatment period
Change in mean volume voided per micturition
Time frame: Within a 12-week treatment period
Change in mean number of nocturia episodes
Time frame: Within a 12-week treatment period
Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume
Time frame: During 12-week 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 31 Oct 2024.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YM178 and tolterodine ER in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 35 sites in 4 countries.
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 5 inclusion and 10 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China, South Korea, Taiwan, India. 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. Some participants in this study may receive a placebo. 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?
Change in mean number of micturitions per 24 hrs (time frame: Within a 12-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01043666, which also lists 1 linked publication.
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 31 Oct 2024.