Urinary Bladder, OveractivePhase 2BlossomNCT01604928
Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder
A Phase 2 study testing YM178 and tolterodine in people with Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 30 sites in 6 countries.
Trial summary
The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 5 Apr 2004to 25 Jan 2005
- Phase
- Phase 2
- 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
- Patient is willing and able to complete the micturition diary correctly.
- Symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for ≥ 3 months
- At randomization:
- Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
- Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period
Who cannot join
- Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants, contraceptive patches and injectable contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator (for female patients confirmed by a cough provocation test)
- Patients with a neurological cause for abnormal detrusor activity
- Diabetic neuropathy
Show all 20Show fewer
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- Uncontrolled narrow angle glaucoma, urinary or gastric retention, colitis ulcerosa, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
- Non-drug treatment including electrostimulation therapy
- (a bladder training program or pelvic floor exercises which started more than 1 month prior to entry into the study can be continued)
- Use of medications intended to treat urinary incontinence or listed in Appendix 1 Part A. Part B lists medications that are restricted but accepted under certain conditions
- Known or suspected hypersensitivity to tolterodine, other anticholinergics, ß-adrenoceptor agonists, or lactose or any of the other inactive ingredients
- Any clinically significant cardiovascular complication including CVA, recent myocardial infarction and uncontrolled hypertension, indicated by a sitting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg
- Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
- Participation in any clinical trial within 30 (90 in the UK) days prior to randomization
- Employees of the sponsor, third parties associated with the study, or the study site
- At randomization:
- Patient who did not complete the micturition diary according to the instructions
- Average total daily urine volume > 3000 ml as recorded in the micturition diary
- Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/L, ASAT or ALAT > 2x upper limit of normal range (ULN), γ-GT > 3x ULN and/or abnormal serum total bilirubin (as assessed in visit 1 samples or alternative sampling within 4 weeks prior to visit 1)
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
Germany7 sites
Site: 32
Bad Ems, 56130
Site: 30
Emmendingen, 79312
Site: 35
Frankfurt, 60326
Site: 34
Hagenow, 19230
Site: 33
Hamburg, 20253
Site: 36
Koblenz, 56068
Site: 31
Trier, 54290
Czechia6 sites
Site: 25
Mělník, 276 01
Site: 22
Prague, 128 08
Site: 24
Prague, 140 59
Site: 20
Prague, 180 81
Site: 21
Ústí nad Labem, 40001
Site: 23
Ústí nad Labem, 401 13
Sweden5 sites
Site: 55
Gothenburg, 413 45
Site: 53
Linköping, 582 24
Site: 50
Lund, 221 85
Site: 51
Stockholm, 141 86
Site: 52
Uppsala, 751 85
United Kingdom5 sites
Site: 64
Bimingham, B15 2TG
Site: 62
London, N19 5LW
Site: 63
London, W1P 7PN
Site: 60
Sheffield, S10 2JF
Site: 61
Swansea, SA6 6NL
Belgium4 sites
Site: 12
Brussels, 1090
Site: 13
Edegem, 2650
Site: 11
Ghent, 9000
Site: 10
Leuven, 3000
Spain3 sites
Site: 42
Alzira-Valencia, 46600
Site: 40
Madrid, 28046
Site: 43
Miranda de Ebro, 09200
About this study
Official title: A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder
The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.
Read the detailed description
This is a multinational, multicenter, double-blind, double-dummy,
randomized, parallel group, placebo and active controlled phase II proof-of concept study. Patients are enrolled into a single-blind, 2-week placebo run in
period after which they are randomized to 4 weeks of double-blind
treatment with YM178 (low dose and high dose), placebo or tolterodine. Subsequently patients will be followed for an additional 2 weeks
with single-blind placebo treatment. There are 6 visits in total: visit 1 at
enrolment, visit 2 (baseline) after the 2-week placebo run-in, visits 3, 4 and 5
after 1, 2 and 4 weeks of double-blind treatment respectively, and visit 6
after a 2-week follow-up.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- YM178, tolterodine, Placebo
- Keywords
- Overactive Bladder, YM178, Mirabegron, Frequency, Urinary urge incontinence, Urgency, Urinary incontinence, 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
tolterodineDrug
Also called Detrusitol
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| YM178 Dose 1 | Experimental | low dose Receives: Drug: YM178 |
| YM178 Dose 2 | Experimental | high dose Receives: Drug: YM178 |
| Tolterodine | Active comparator | Oral Receives: Drug: tolterodine |
| Placebo | Placebo comparator | Oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean number of micturitions per 24 hours
Measured: Baseline and 4 weeks (end of treatment)
Secondary outcomes (4)
Change from baseline in mean number of urgency episodes/24 hours
Measured: Baseline and 4 weeks (end of treatment)
Change from baseline in mean volume voided per micturition
Measured: Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of urge incontinence episodes/24 hours
Measured: Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of incontinence episodes/24 hours
Measured: Baseline and 4 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study start5 Apr 2004
- Primary completion25 Jan 2005
- Study completion25 Jan 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604928
- Sponsor's protocol ID
- 178-CL-008
- Acronym
- Blossom
- Status last verified
- Oct 2024
- First submitted
- 22 May 2012
- 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
Chapple CR, Amarenco G, Lopez Aramburu MA, Everaert K, Liehne J, Lucas M, Vik V, Ridder A, Snijder R, Yamaguchi O; BLOSSOM Investigator Group. A proof-of-concept study: mirabegron, a new therapy for overactive bladder. Neurourol Urodyn. 2013 Nov;32(8):1116-22. doi: 10.1002/nau.22373. Epub 2013 Feb 19.
PubMed 23424164
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
- A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder
- ClinicalTrials.gov ID
- NCT01604928
- Acronym / sponsor ID
- Blossom / 178-CL-008
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive Bladder, YM178, Mirabegron, Frequency, Urinary urge incontinence, Urgency, Urinary incontinence, Micturition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2004 (actual)
- Primary completion
- 25 Jan 2005 (actual)
- Study completion
- 25 Jan 2005 (actual)
- First posted
- 24 May 2012 (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 efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.
Detailed description
This is a multinational, multicenter, double-blind, double-dummy,
randomized, parallel group, placebo and active controlled phase II proof-of concept study. Patients are enrolled into a single-blind, 2-week placebo run in
period after which they are randomized to 4 weeks of double-blind
treatment with YM178 (low dose and high dose), placebo or tolterodine. Subsequently patients will be followed for an additional 2 weeks
with single-blind placebo treatment. There are 6 visits in total: visit 1 at
enrolment, visit 2 (baseline) after the 2-week placebo run-in, visits 3, 4 and 5
after 1, 2 and 4 weeks of double-blind treatment respectively, and visit 6
after a 2-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YM178 Dose 1 | Experimental | Drug: YM178low dose |
| YM178 Dose 2 | Experimental | Drug: YM178high dose |
| Tolterodine | Active comparator | Drug: tolterodineOral |
| Placebo | Placebo comparator | Drug: PlaceboOral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is willing and able to complete the micturition diary correctly.
- Symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for ≥ 3 months
- Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
- Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period
Key exclusion criteria (20 listed)
- Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants, contraceptive patches and injectable contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator (for female patients confirmed by a cough provocation test)
- Patients with a neurological cause for abnormal detrusor activity
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 Dose 1, YM178 Dose 2 |
| tolterodineAlso: DetrusitolOral | Drug | Tolterodine |
| PlaceboOral | Drug | Placebo |
Primary outcome
Change from baseline in mean number of micturitions per 24 hours
Time frame: Baseline and 4 weeks (end of treatment)
4 secondary outcomes
Change from baseline in mean number of urgency episodes/24 hours
Time frame: Baseline and 4 weeks (end of treatment)
Change from baseline in mean volume voided per micturition
Time frame: Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of urge incontinence episodes/24 hours
Time frame: Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of incontinence episodes/24 hours
Time frame: Baseline and 4 weeks (end 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 31 Oct 2024.
- Derived from this study: PubMed 23424164Chapple CR, Amarenco G, Lopez Aramburu MA, Everaert K, Liehne J, Lucas M, Vik V, Ridder A, Snijder R, Yamaguchi O; BLOSSOM Investigator Group. A proof-of-concept study: mirabegron, a new therapy for overactive bladder. Neurourol Urodyn. 2013 Nov;32(8):1116-22. doi: 10.1002/nau.22373. Epub 2013 Feb 19.
- 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/.
Related trials for Urinary Bladder, Overactive
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
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.
Clinical Study Manager study director
Astellas Pharma Europe B.V.
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM178 and tolterodine in people with Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 30 sites in 6 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 20 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 30 sites in Germany, Czechia, Sweden, United Kingdom, Belgium and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mean number of micturitions per 24 hours (time frame: Baseline and 4 weeks (end of treatment)). 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 NCT01604928, 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; AzTrials last refreshed its copy on 7 Nov 2026.