Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder
Blossom
A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder
1 other identifier
interventional
260
6 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2004
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2005
CompletedFirst Submitted
Initial submission to the registry
May 22, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedOctober 31, 2024
October 1, 2024
10 months
May 22, 2012
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean number of micturitions per 24 hours
Baseline and 4 weeks (end of treatment)
Secondary Outcomes (4)
Change from baseline in mean number of urgency episodes/24 hours
Baseline and 4 weeks (end of treatment)
Change from baseline in mean volume voided per micturition
Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of urge incontinence episodes/24 hours
Baseline and 4 weeks (end of treatment)
Change from baseline in mean number of incontinence episodes/24 hours
Baseline and 4 weeks (end of treatment)
Study Arms (4)
YM178 Dose 1
EXPERIMENTALlow dose
YM178 Dose 2
EXPERIMENTALhigh dose
Tolterodine
ACTIVE COMPARATOROral
Placebo
PLACEBO COMPARATOROral
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Site: 12
Brussels, 1090, Belgium
Site: 13
Edegem, 2650, Belgium
Site: 11
Ghent, 9000, Belgium
Site: 10
Leuven, 3000, Belgium
Site: 25
Mělník, 276 01, Czechia
Site: 22
Prague, 128 08, Czechia
Site: 24
Prague, 140 59, Czechia
Site: 20
Prague, 180 81, Czechia
Site: 21
Ústí nad Labem, 40001, Czechia
Site: 23
Ústí nad Labem, 401 13, Czechia
Site: 32
Bad Ems, 56130, Germany
Site: 30
Emmendingen, 79312, Germany
Site: 35
Frankfurt, 60326, Germany
Site: 34
Hagenow, 19230, Germany
Site: 33
Hamburg, 20253, Germany
Site: 36
Koblenz, 56068, Germany
Site: 31
Trier, 54290, Germany
Site: 42
Alzira-Valencia, 46600, Spain
Site: 40
Madrid, 28046, Spain
Site: 43
Miranda de Ebro, 09200, Spain
Site: 55
Gothenburg, 413 45, Sweden
Site: 53
Linköping, 582 24, Sweden
Site: 50
Lund, 221 85, Sweden
Site: 51
Stockholm, 141 86, Sweden
Site: 52
Uppsala, 751 85, Sweden
Site: 64
Bimingham, B15 2TG, United Kingdom
Site: 62
London, N19 5LW, United Kingdom
Site: 63
London, W1P 7PN, United Kingdom
Site: 60
Sheffield, S10 2JF, United Kingdom
Site: 61
Swansea, SA6 6NL, United Kingdom
Related Publications (1)
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.
PMID: 23424164DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Study Manager
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2012
First Posted
May 24, 2012
Study Start
April 5, 2004
Primary Completion
January 25, 2005
Study Completion
January 25, 2005
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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/.