A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
NCT ID: NCT01340027
Last Updated: 2024-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1307 participants
INTERVENTIONAL
2011-03-29
2012-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received matching placebo tablets orally once a day for 12 weeks
Placebo
oral
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks
Solifenacin succinate
oral
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks
Solifenacin succinate
oral
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks
Solifenacin succinate
oral
Solifenacin 2.5 mg and Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Solifenacin succinate
oral
Solifenacin 2.5 mg and Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Solifenacin succinate
oral
Solifenacin 5 mg and Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Solifenacin succinate
oral
Solifenacin 5 mg and Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Solifenacin succinate
oral
Solifenacin 10 mg and Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Solifenacin succinate
oral
Solifenacin 10 mg and Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Mirabegron
oral
Solifenacin succinate
oral
Interventions
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Mirabegron
oral
Solifenacin succinate
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients;
* Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis \[MS\] and Parkinson's disease);
* Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg;
* Subject has evidence of a urinary tract infection (UTI) (urine culture containing \> 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was \> 28 days;
* Subject has a QT interval \> 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;
* Subject has clinically significant abnormalities on the 12 lead electrocardiogram (ECG);
* Subject has serum creatinine \> 150 µmol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2x upper limit of normal (ULN), gamma-glutamyltransferase (γ-GT) \> 3x ULN, or total bilirubin \> 2x ULN, as assessed in Screening samples;
* Subject had an average total daily urine volume \> 3000 mL as recorded in the micturition diary period;
* Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Physician
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Bristol Urological Institute
Locations
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BY37101
Minsk, , Belarus
BY37102
Minsk, , Belarus
BY37103
Minsk, , Belarus
BY37104
Vitebsk, , Belarus
BE32102
Brussels, , Belgium
BE32104
Edegem, , Belgium
BE32103
Ghent, , Belgium
BE32101
Leuven, , Belgium
CZ42005
Bohumín, , Czechia
CZ42003
Hradec Králové, , Czechia
CZ42011
Ostrava, , Czechia
CZ42006
Pilsen, , Czechia
CZ42001
Prague, , Czechia
CZ42007
Prague, , Czechia
CZ42009
Prague, , Czechia
CZ42010
Roudnice nad Labem, , Czechia
CZ42012
Sternberk, , Czechia
CZ42002
Uherské Hradiště, , Czechia
DK45101
Aarhus N, , Denmark
DK45102
Herlev, , Denmark
DK45104
Holstebro, , Denmark
FI35803
Helsinki, , Finland
FI35804
Kouvola, , Finland
FI35801
Oulu, , Finland
FI35802
Tampere, , Finland
FR33104
Colmar, , France
FR33108
Dijon, , France
FR33103
Orléans, , France
FR33111
Paris, , France
FR33112
Paris, , France
FR33106
Toulouse, , France
FR33110
Tours, , France
DE49109
Bad Ems, , Germany
DE49103
Göttingen, , Germany
DE49117
Hagenow, , Germany
DE49105
Hettstedt, , Germany
DE49108
Leipzig, , Germany
DE49110
Neustadt in Sachsen, , Germany
DE49118
Reutlingen, , Germany
DE49101
Rostock, , Germany
DE49111
Sangerhausen, , Germany
DE49104
Wismar, , Germany
HU36108
Csongrád, , Hungary
HU36101
Győr, , Hungary
HU36106
Körmend, , Hungary
HU36110
Miskolc, , Hungary
HU36104
Sopron, , Hungary
HU36103
Szekszárd, , Hungary
HU36107
Tatabánya, , Hungary
IT39103
Avellino, , Italy
IT39101
Catanzaro, , Italy
IT39105
Florence, , Italy
IT39102
Treviglio (BG), , Italy
NL31104
Amsterdam, , Netherlands
NL31106
Maastricht, , Netherlands
NL31102
Sneek, , Netherlands
NL31101
Winterswijk, , Netherlands
NO47104
Elverum, , Norway
NO47102
Hamar, , Norway
PL48107
Krakow, , Poland
PL48103
Lodz, , Poland
PL48108
Lublin, , Poland
PL48106
Piaseczno, , Poland
PL48104
Puławy, , Poland
PL48101
Warsaw, , Poland
PL48105
Warsaw, , Poland
PL48112
Więcbork, , Poland
PL48111
Wroclaw, , Poland
PT35102
Coimbra, , Portugal
PT35105
Coimbra, , Portugal
PT35104
Lisbon, , Portugal
PT35107
Lisbon, , Portugal
PT35110
Porto, , Portugal
PT35101
Porto, , Portugal
PT35106
Tomar, , Portugal
RO40106
Brasov, , Romania
RO40102
Bucharest, , Romania
RO40104
Bucharest, , Romania
RO40103
Bucharest, , Romania
RO40108
Bucharest, , Romania
RO40101
Craiova, , Romania
RO40105
Craiova, , Romania
RO40107
Sibiu, , Romania
RU70112
Kazan', , Russia
RU70108
Moscow, , Russia
RU70110
Moscow, , Russia
RU70102
Saint Petersburg, , Russia
RU70103
Saint Petersburg, , Russia
RU70106
Saint Petersburg, , Russia
RU70101
Saint Petersburg, , Russia
RU70107
Saint Petersburg, , Russia
RU70109
Saint Petersburg, , Russia
RU70113
Ufa, , Russia
SK42109
Banská Bystrica, , Slovakia
SK42112
Bratislava, , Slovakia
SK42107
Košice, , Slovakia
SK42113
Malacky, , Slovakia
SK42104
Nitra, , Slovakia
SK42105
Pieštany, , Slovakia
SK42106
Piešťany, , Slovakia
SK42102
Prešov, , Slovakia
SK42108
Trenčín, , Slovakia
SK42101
Trenčín, , Slovakia
SK42103
Žilina, , Slovakia
ES34103
Madrid, , Spain
ES34101
Madrid, , Spain
ES34109
Madrid, , Spain
ES34102
Madrid, , Spain
ES34105
Pamplona, , Spain
ES34104
Sant Joan d'Alacant, , Spain
ES34107
Seville, , Spain
SE46101
Gothenburg, , Sweden
SE46103
Karlshamn, , Sweden
SE46104
Malmo, , Sweden
SE46102
Stockholm, , Sweden
SE46105
Tanumshede, , Sweden
UA38104
Dnipro, , Ukraine
UA38102
Donetsk, , Ukraine
UA38111
Donetsk, , Ukraine
UA38106
Kiev, , Ukraine
UA38109
Kiev, , Ukraine
UA38107
Lviv, , Ukraine
UA38101
Odesa, , Ukraine
UA38103
Zaporizhzhya, , Ukraine
GB44103
Bristol, , United Kingdom
GB44108
Cambridge, , United Kingdom
GB44106
Garston, , United Kingdom
GB44111
Glasgow, , United Kingdom
GB44104
Nantwich, , United Kingdom
GB44110
Northwood, , United Kingdom
GB44107
Plymouth, , United Kingdom
GB44101
Reading, , United Kingdom
GB44105
Sandbach, , United Kingdom
Countries
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References
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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.
Abrams 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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2010-020601-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
178-CL-100
Identifier Type: -
Identifier Source: org_study_id
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