Urinary Bladder, OveractivePhase 3NCT00966004
A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder
A Phase 3 study testing YM178 and tolterodine in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 4 sites in Japan.
Trial summary
The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration. 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 and tolterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,139 participants
- Where
- 4 sitesJapan
- Study dates
- 24 Jul 2009to 15 Feb 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
- Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period
- Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
- Patient with an average frequency of micturition of 8 or more times per 24-hour period
- Written informed consent has been obtained
Who cannot join
- Patients without experience of urge incontinence before informed consent
- Patients given a clear diagnosis of stress incontinence
- Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)
- Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis
- Patients with a previous history of recurrent urinary tract infection
- Patients complicated with or with a history of bladder tumor or prostatic tumor
Show all 17Show fewer
- Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease
- Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period
- Patients with an indwelling catheter or practicing intermittent self-catheterization
- Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia
- Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period
- Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or < 50 bpm
- Patients with polyuria exceeding 3000 mL in mean daily urine volume
- Patients meeting any of the following in the examinations
- Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee
- Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)
- Patients with a blood creatinine level ≥ 2.0 mg/dL
Trial locations and contacts
4 sites in 1 country.
About this study
Official title: Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder
The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.
Read the detailed description
This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test.
The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).
- Conditions
- Urinary Bladder, Overactive
- Being tested
- YM178, Placebo, tolterodine
- Keywords
- Urge incontinence, YM178, Overactive Bladder, Urgency, Urinary incontinence, mirabegron, Micturition
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence
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
tolterodineDrug
Also called Detrol, Detrusitol
oral
| Study group | Role | What they receive |
|---|---|---|
| YM178 group | Experimental | oral Receives: Drug: YM178 |
| Placebo group | Placebo comparator | oral Receives: Drug: Placebo |
| tolterodine group | Active comparator | oral Receives: Drug: tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean number of micturitions per 24 hours
Measured: Within a 12-week treatment period
Secondary outcomes (6)
Change from baseline in the mean number of urgency episodes per 24 hours
Measured: Within a 12-week treatment period
Change from baseline in the mean number of urinary incontinence episode per 24 hours
Measured: Within a 12-week treatment period
Change from baseline in the mean number of urge incontinence episodes per 24 hours
Measured: Within a 12-week treatment period
Change from baseline in the mean volume voided per micturition
Measured: Within a 12-week treatment period
Change from baseline in mean number of nocturia episodes
Measured: Within a 12-week treatment period
Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire
Measured: Within a 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study start24 Jul 2009
- Primary completion15 Feb 2010
- Study completion15 Feb 2010
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
- 1,139 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
- NCT00966004
- Sponsor's protocol ID
- 178-CL-048
- Status last verified
- Oct 2024
- First submitted
- 24 Aug 2009
- 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 Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00966004
- Acronym / sponsor ID
- 178-CL-048
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Urge incontinence, YM178, Overactive Bladder, Urgency, Urinary incontinence, mirabegron, Micturition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,139 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2009 (actual)
- Primary completion
- 15 Feb 2010 (actual)
- Study completion
- 15 Feb 2010 (actual)
- First posted
- 26 Aug 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 purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.
Detailed description
This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test.
The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).
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 group | Active comparator | Drug: tolterodineoral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period
- Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
- Patient with an average frequency of micturition of 8 or more times per 24-hour period
- Written informed consent has been obtained
Key exclusion criteria (17 listed)
- Patients without experience of urge incontinence before informed consent
- Patients given a clear diagnosis of stress incontinence
- Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)
- Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis
- Patients with a previous history of recurrent urinary tract infection
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 |
| tolterodineAlso: Detrol, Detrusitoloral | Drug | tolterodine group |
Primary outcome
Change from baseline in the mean number of micturitions per 24 hours
Time frame: Within a 12-week treatment period
6 secondary outcomes
Change from baseline in the mean number of urgency episodes per 24 hours
Time frame: Within a 12-week treatment period
Change from baseline in the mean number of urinary incontinence episode per 24 hours
Time frame: Within a 12-week treatment period
Change from baseline in the mean number of urge incontinence episodes per 24 hours
Time frame: Within a 12-week treatment period
Change from baseline in the mean volume voided per micturition
Time frame: Within a 12-week treatment period
Change from baseline in mean number of nocturia episodes
Time frame: Within a 12-week treatment period
Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire
Time frame: Within a 12-week treatment 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 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
4 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 and tolterodine in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 4 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 4 inclusion and 17 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 4 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. 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 from baseline in the mean number of micturitions per 24 hours (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 NCT00966004, 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.