A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
Symphony
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.
2 other identifiers
interventional
1,307
19 countries
129
Brief Summary
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Shorter than P25 for phase_2
129 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
March 29, 2011
CompletedFirst Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
April 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2012
CompletedResults Posted
Study results publicly available
July 21, 2015
CompletedOctober 31, 2024
October 1, 2024
1.3 years
April 20, 2011
June 23, 2015
October 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
Baseline and Week 12
Secondary Outcomes (29)
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Week 12
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With a Micturition Response
Baseline and Weeks 2, 4, 8 and 12
- +24 more secondary outcomes
Study Arms (12)
Placebo
PLACEBO COMPARATORParticipants received matching placebo tablets orally once a day for 12 weeks
Mirabegron 25 mg
ACTIVE COMPARATORParticipants received mirabegron 25 mg tablets orally once a day for 12 weeks
Mirabegron 50 mg
ACTIVE COMPARATORParticipants received mirabegron 50 mg tablets orally once a day for 12 weeks
Solifenacin 2.5 mg
ACTIVE COMPARATORParticipants received solifenacin 2.5 mg tablets orally once a day for 12 weeks
Solifenacin 5 mg
ACTIVE COMPARATORParticipants received solifenacin 5 mg tablets orally once a day for 12 weeks
Solifenacin 10 mg
ACTIVE COMPARATORParticipants received solifenacin 10 mg tablets orally once a day for 12 weeks
Solifenacin 2.5 mg and Mirabegron 25 mg
EXPERIMENTALParticipants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Solifenacin 2.5 mg and Mirabegron 50 mg
EXPERIMENTALParticipants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Solifenacin 5 mg and Mirabegron 25 mg
EXPERIMENTALParticipants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Solifenacin 5 mg and Mirabegron 50 mg
EXPERIMENTALParticipants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Solifenacin 10 mg and Mirabegron 25 mg
EXPERIMENTALParticipants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Solifenacin 10 mg and Mirabegron 50 mg
EXPERIMENTALParticipants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Interventions
oral
oral
Eligibility Criteria
You may qualify if:
- Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m\^2 and a total body weight between 50 and 95 kg;
- Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
- Subject has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months.
- Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition);
- Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.
You may not qualify if:
- Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of childbearing potential;
- Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration.
- Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- Subject has significant post-void residual (PVR) volume (\> 150 mL);
- Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation test);
- Subject has a neurological cause for detrusor overactivity;
- Subject has an indwelling catheter or practices intermittent self-catheterization;
- Subject has diabetic neuropathy;
- Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
- Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
- Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
- Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated;
- Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke;
- Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening);
- Subject is using medications intended to treat OAB or prohibited medications.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (133)
BY37101
Minsk, 220036, Belarus
BY37102
Minsk, 220119, Belarus
BY37103
Minsk, 223010, Belarus
BY37104
Vitebsk, 210037, Belarus
BE32102
Brussels, 1090, Belgium
BE32104
Edegem, 2650, Belgium
BE32103
Ghent, 9000, Belgium
BE32101
Leuven, 3000, Belgium
CZ42005
Bohumín, 73581, Czechia
CZ42003
Hradec Králové, 500 02, Czechia
CZ42011
Ostrava, 700 30, Czechia
CZ42006
Pilsen, 301 24, Czechia
CZ42001
Prague, 128 51, Czechia
CZ42007
Prague, 14000, Czechia
CZ42009
Prague, 15006, Czechia
CZ42010
Roudnice nad Labem, 413 01, Czechia
CZ42012
Sternberk, 78501, Czechia
CZ42002
Uherské Hradiště, 68608, Czechia
DK45101
Aarhus N, 8200, Denmark
DK45102
Herlev, 2730, Denmark
DK45104
Holstebro, 7500, Denmark
FI35803
Helsinki, 00029, Finland
FI35804
Kouvola, 45200, Finland
FI35801
Oulu, 90220, Finland
FI35802
Tampere, 33521, Finland
FR33104
Colmar, 68024, France
FR33108
Dijon, 21079, France
FR33103
Orléans, 45067, France
FR33111
Paris, 75651, France
FR33112
Paris, 75970, France
FR33106
Toulouse, 31059, France
FR33110
Tours, 37044, France
DE49109
Bad Ems, 56130, Germany
DE49103
Göttingen, 37075, Germany
DE49117
Hagenow, 19230, Germany
DE49105
Hettstedt, 06333, Germany
DE49108
Leipzig, 04105, Germany
DE49110
Neustadt in Sachsen, 01844, Germany
DE49118
Reutlingen, 72764, Germany
DE49101
Rostock, 18107, Germany
DE49111
Sangerhausen, 06526, Germany
DE49104
Wismar, 23970, Germany
HU36108
Csongrád, 6640, Hungary
HU36101
Győr, 9024, Hungary
HU36106
Körmend, 9900, Hungary
HU36110
Miskolc, 3526, Hungary
HU36104
Sopron, 9400, Hungary
HU36103
Szekszárd, 7100, Hungary
HU36107
Tatabánya, 2800, Hungary
IT39103
Avellino, 83100, Italy
IT39101
Catanzaro, 88100, Italy
IT39105
Florence, 50139, Italy
IT39102
Treviglio (BG), 24047, Italy
NL31104
Amsterdam, 1100 AD, Netherlands
NL31106
Maastricht, Netherlands
NL31102
Sneek, 8601 ZK, Netherlands
NL31101
Winterswijk, 7101 BN, Netherlands
NO47104
Elverum, 2408, Norway
NO47102
Hamar, 2317, Norway
PL48107
Krakow, 31-530, Poland
PL48103
Lodz, 90-602, Poland
PL48108
Lublin, 20-954, Poland
PL48106
Piaseczno, 05-500, Poland
PL48104
Puławy, 24-100, Poland
PL48101
Warsaw, 02-507, Poland
PL48105
Warsaw, 02-929, Poland
PL48112
Więcbork, 89-410, Poland
PL48111
Wroclaw, 01-432, Poland
PT35102
Coimbra, 3000-075, Portugal
PT35105
Coimbra, 3041-801, Portugal
PT35104
Lisbon, 1050-199, Portugal
PT35107
Lisbon, 1649-035, Portugal
PT35110
Porto, 4099-001, Portugal
PT35101
Porto, 4200-319, Portugal
PT35106
Tomar, 2304-909, Portugal
RO40106
Brasov, 500152, Romania
RO40102
Bucharest, 042122, Romania
RO40104
Bucharest, 050659, Romania
RO40103
Bucharest, 200642, Romania
RO40108
Bucharest, 22328, Romania
RO40101
Craiova, 20116, Romania
RO40105
Craiova, 20116, Romania
RO40107
Sibiu, 550245, Romania
RU70112
Kazan', 420012, Russia
RU70108
Moscow, 105425, Russia
RU70110
Moscow, 115682, Russia
RU70102
Saint Petersburg, 191015, Russia
RU70103
Saint Petersburg, 194178, Russia
RU70106
Saint Petersburg, 197089, Russia
RU70101
Saint Petersburg, 197136, Russia
RU70107
Saint Petersburg, 198013, Russia
RU70109
Saint Petersburg, 198103, Russia
RU70113
Ufa, 450096, Russia
SK42109
Banská Bystrica, 975 01, Slovakia
SK42112
Bratislava, 832 63, Slovakia
SK42107
Košice, 04011, Slovakia
SK42113
Malacky, 90101, Slovakia
SK42104
Nitra, 949 01, Slovakia
SK42105
Pieštany, 921 01, Slovakia
SK42106
Piešťany, 921 01, Slovakia
SK42102
Prešov, 08001, Slovakia
SK42108
Trenčín, 911 01, Slovakia
SK42101
Trenčín, 91101, Slovakia
SK42103
Žilina, Slovakia
ES34103
Madrid, 28031, Spain
ES34101
Madrid, 28041, Spain
ES34109
Madrid, 28046, Spain
ES34102
Madrid, 28905, Spain
ES34105
Pamplona, 31008, Spain
ES34104
Sant Joan d'Alacant, 03550, Spain
ES34107
Seville, 41014, Spain
SE46101
Gothenburg, 41263, Sweden
SE46103
Karlshamn, 37435, Sweden
SE46104
Malmo, 21152, Sweden
SE46102
Stockholm, 14186, Sweden
SE46105
Tanumshede, 45781, Sweden
UA38104
Dnipro, 49005, Ukraine
UA38102
Donetsk, 83003, Ukraine
UA38111
Donetsk, 83114, Ukraine
UA38106
Kiev, 01023, Ukraine
UA38109
Kiev, 04053, Ukraine
UA38107
Lviv, 79044, Ukraine
UA38101
Odesa, Ukraine
UA38103
Zaporizhzhya, 69600, Ukraine
GB44103
Bristol, BS10 5NB, United Kingdom
GB44108
Cambridge, CB2 2QQ, United Kingdom
GB44106
Garston, WD25 0EA, United Kingdom
GB44111
Glasgow, G20 0XA, United Kingdom
GB44104
Nantwich, CW5 5NX, United Kingdom
GB44110
Northwood, HA6 2RN, United Kingdom
GB44107
Plymouth, PL6 8DH, United Kingdom
GB44101
Reading, RG1 5AN, United Kingdom
GB44105
Sandbach, CW11 1EQ, United Kingdom
Related Publications (2)
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.
PMID: 37160401DERIVEDAbrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, Newgreen D, Paireddy A, van Maanen R, Ridder A. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015 Mar;67(3):577-88. doi: 10.1016/j.eururo.2014.02.012. Epub 2014 Feb 19.
PMID: 24612659DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Director
- Organization
- Astellas Pharma Europe, B.V.
Study Officials
- STUDY DIRECTOR
Study Physician
Astellas Pharma Europe B.V.
- PRINCIPAL INVESTIGATOR
Principal Investigator
Bristol Urological Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2011
First Posted
April 21, 2011
Study Start
March 29, 2011
Primary Completion
June 28, 2012
Study Completion
June 28, 2012
Last Updated
October 31, 2024
Results First Posted
July 21, 2015
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/.