- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01638000
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment. (BEYOND)
November 20, 2017 updated by: Astellas Pharma Europe Ltd.
A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1887
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Yerevan, Armenia, 0001
- Site: 37406
-
Yerevan, Armenia, 0014
- Site: 37404
-
Yerevan, Armenia, 0052
- Site: 37403
-
Yerevan, Armenia, 0078
- Site: 37401
-
Yerevan, Armenia, 0078
- Site: 37402
-
-
-
-
-
Baden, Austria, 2500
- Site: 43006
-
Graz, Austria, 9036
- Site: 43014
-
Innsbruck, Austria, 6020
- Site: 43015
-
Linz, Austria, 4020
- Site: 43013
-
Oberwart, Austria, 7400
- Site: 43005
-
Vienna, Austria, 1020
- Site: 43011
-
Vienna, Austria, 1220
- Site: 43002
-
Wels, Austria, 4600
- Site: 43003
-
-
-
-
-
Minsk, Belarus, 220119
- Site: 37502
-
Minsk, Belarus, 223041
- Site: 37501
-
Vitebsk, Belarus, 210037
- Site: 37504
-
-
-
-
-
Brussels, Belgium, 1070
- Site: 32006
-
Deurne, Belgium, 2100
- Site: 32008
-
Edegem, Belgium, 2650
- Site: 32001
-
Gent, Belgium, 9000
- Site: 32004
-
Leuven, Belgium, 3000
- Site: 32007
-
Liege, Belgium
- Site: 32005
-
-
-
-
-
Burgas, Bulgaria, 8000
- Site: 35902
-
Haskovo, Bulgaria, 6300
- Site: 35909
-
Lovech, Bulgaria, 5500
- Site: 35901
-
Plovdiv, Bulgaria, 4003
- Site: 35905
-
Sofia, Bulgaria, 1431
- Site: 35906
-
Sofia, Bulgaria, 1504
- Site: 35908
-
Sofia, Bulgaria, 1606
- Site: 35903
-
-
-
-
-
Abbotsford, Canada, V2S 3N5
- Site: 10010
-
Barrie, Canada, L4M 7G1
- Site: 10011
-
Bathurst, Canada, E2A 4Z2
- Site: 10001
-
Brampton, Canada, L6T 4S5
- Site: 10003
-
Brantford, Canada, N3R 4N3
- Site: 10005
-
Kingston, Canada, K7L 3J7
- Site: 10007
-
Montreal, Canada, H4N 3C5
- Site: 10002
-
Sherbrooke, Canada, J1H 5N4
- Site: 10009
-
Toronto, Canada, M4N 3M5
- Site: 10004
-
Victoria, Canada, V8V 3N1
- Site: 10008
-
-
-
-
-
Bohumin, Czechia, 73581
- Site: 42004
-
Brno, Czechia, 602 00
- Site: 42003
-
Hradec Kralove, Czechia, 500 05
- Site: 42001
-
Jihlava, Czechia, 586 33
- Site: 42002
-
Plzen-Lochotin, Czechia, 30460
- Site: 42006
-
Prague, Czechia, 128 51
- Site: 42008
-
Prague 1, Czechia, 110 00
- Site: 42005
-
Prague 4, Czechia, 14000
- Site: 42007
-
-
-
-
-
Aalborg, Denmark, 9000
- Site: 45002
-
Aarhus N, Denmark, 8200
- Site: 45001
-
Frederiksbjerg, Denmark, 2000
- Site: 45005
-
Hvidovre, Denmark, 2650
- Site: 45004
-
Odense C, Denmark, 9000
- Site: 45003
-
-
-
-
-
Jyvaskyla, Finland, 40620
- Site: 35802
-
Oulu, Finland, 90029
- Site: 35801
-
Tampere, Finland, 33521
- Site: 35804
-
-
-
-
-
Angers, France, 49033
- Site: 33010
-
Colmar Cedex, France, 68024
- Site: 33007
-
Dijon, France, 21000
- Site: 33011
-
Marseille, France, 13285
- Site: 33002
-
Marseille, France, 13385
- Site: 33006
-
Nimes, France, 30029
- Site: 33013
-
Orleans Cedex 2, France, 45067
- Site: 33004
-
Paris Cedex 20, France, 75970
- Site: 33001
-
Paris Cedex 20, France, 75970
- Site: 33005
-
Rouen, France, 76031
- Site: 33003
-
Suresnes Cedex, France, 92151
- Site: 33014
-
Tours, France, 37044
- Site: 33017
-
Valence, France, 26953
- Site: 33015
-
-
-
-
-
Tbilisi, Georgia, 144
- Site: 99501
-
Tbilisi, Georgia, 159
- Site: 99502
-
Tbilisi, Georgia, 159
- Site: 99503
-
-
-
-
-
Bad Ems, Germany, 56130
- Site: 49006
-
Halle Saale, Germany, 06132
- Site: 49009
-
-
-
-
-
Alexandroupoli, Greece, 68100
- Site: 30005
-
Athens, Greece
- Site: 30001
-
Athens, Greece, 115 28
- Site: 30009
-
Athens, Greece, 166 73
- Site: 30007
-
Herakleion, Greece, 711 10
- Site: 30006
-
Larisa, Greece, 41334
- Site: 30008
-
Patras, Greece, 26500
- Site: 30004
-
Thessaloniki, Greece, 546 42
- Site: 30010
-
Thessaloniki, Greece, 56429
- Site: 30002
-
-
-
-
-
Budapest, Hungary, 1082
- Site: 36003
-
Budapest, Hungary, 1237
- Site: 36004
-
Csongrad, Hungary, H-6640
- Site: 36005
-
Nyiregyhaza, Hungary, H-4400
- Site: 36006
-
Salgotarjan, Hungary, 3100
- Site: 36001
-
Szekszard, Hungary, 7100
- Site: 36002
-
-
-
-
-
Cork, Ireland
- Site: 35304
-
Dublin, Ireland, 8
- Site: 35302
-
Dublin, Ireland, 8
- Site: 35306
-
Dublin, Ireland, 9
- Site: 35301
-
Tralee, Ireland
- Site: 35303
-
Waterford, Ireland
- Site: 35305
-
-
-
-
-
Avellino, Italy, 83100
- Site: 39001
-
Catanzaro, Italy, 88100
- Site: 39005
-
Cinisello Balsamo, Italy, 20092
- Site: 39003
-
Florence, Italy, 50139
- Site: 39002
-
Milan, Italy, 20153
- Site: 39008
-
Pavia, Italy, 27100
- Site: 39010
-
Perugia, Italy, 06156
- Site: 39006
-
Treviglio, Italy, 24047
- Site: 39007
-
-
-
-
-
Almaty, Kazakhstan, 050060
- Site: 77705
-
Almaty, Kazakhstan, 50091
- Site: 77706
-
Astana, Kazakhstan, 010000
- Site: 77703
-
Astana, Kazakhstan, 10000
- Site: 77702
-
-
-
-
-
Liepaja, Latvia, LV-3401
- Site: 37103
-
Riga, Latvia, 1038
- Site: 37102
-
Riga, Latvia, LV-1002
- Site: 37101
-
-
-
-
-
Achrafieh, Lebanon
- Site: 96103
-
Jbeil, Lebanon
- Site: 96102
-
-
-
-
-
Kaunas, Lithuania, 50219
- Site: 37001
-
Vilnius, Lithuania, LT-01118
- Site: 37003
-
-
-
-
-
Amsterdam, Netherlands
- Site: 31010
-
Eindhoven, Netherlands, 5623 EJ
- Site: 31005
-
Enschede, Netherlands, 7511 JX
- Site: 31004
-
Nijmegen, Netherlands, 6525 GA
- Site: 31007
-
Tilburg, Netherlands, 5022 GC
- Site: 31001
-
Utrecht, Netherlands, 3584 CX
- Site: 31008
-
Zwolle, Netherlands, 8025 AB
- Site: 31006
-
-
-
-
-
Hamar, Norway, 2317
- Site: 47002
-
Tonsberg, Norway, 3103
- Site: 47001
-
Trondheim, Norway, 7006
- Site: 47005
-
-
-
-
-
Kolbuszowa Dolna, Poland, 36-100
- Site: 48007
-
Krakow, Poland, 31-315
- Site: 48006
-
Lublin, Poland, 20-632
- Site: 48001
-
Piaseczno, Poland, 05-500
- Site: 48004
-
Warsaw, Poland, 02-929
- Site: 48003
-
Wroclaw, Poland, 01-432
- Site: 48005
-
-
-
-
-
Lisbon, Portugal, 1050-199
- Site: 35105
-
Lisbon, Portugal, 1649-035
- Site: 35104
-
Matosinhos, Portugal, 4454-509
- Site: 35102
-
Porto, Portugal, 4100-180
- Site: 35103
-
Setubal, Portugal, 2910-446
- Site: 35101
-
-
-
-
-
Moscow, Russian Federation, 101000
- Site: 70007
-
Moscow, Russian Federation, 105425
- Site: 70001
-
Moscow, Russian Federation, 115516
- Site: 70008
-
Moscow, Russian Federation, 117815
- Site: 70005
-
Moscow, Russian Federation, 117815
- Site: 70006
-
Moscow, Russian Federation, 117997
- Site: 70011
-
Moscow, Russian Federation, 119435
- Site: 70002
-
Moscow, Russian Federation, 125206
- Site: 70003
-
Saint Petersburg, Russian Federation, 194175
- Site: 70013
-
Saint Petersburg, Russian Federation, 196084
- Site: 70012
-
Saint Petersburg, Russian Federation, 198103
- Site: 70010
-
Saint Petersburg, Russian Federation, 199034
- Site: 70009
-
St. Petersburg, Russian Federation, 197089
- Site: 70004
-
-
-
-
-
Galanta, Slovakia, 924 22
- Site: 42104
-
Martin, Slovakia, 036 59
- Site: 42106
-
Piestany, Slovakia, 92102
- Site: 42103
-
Poprad, Slovakia, 05801
- Site: 42101
-
Trencin, Slovakia, 911 01
- Site: 42105
-
Zilina, Slovakia, 010 01
- Site: 42102
-
-
-
-
-
Ljubljana, Slovenia, 1000
- Site: 38603
-
Ljubljana, Slovenia, 1000
- Site: 38604
-
Maribor, Slovenia, 2000
- Site: 38601
-
Maribor, Slovenia, 2000
- Site: 38602
-
Novo Mesto, Slovenia, 8000
- Site: 38606
-
-
-
-
-
Barcelona, Spain, 080200
- Site: 34001
-
Barcelona, Spain, 08036
- Site: 34002
-
Bilbao, Spain, 48013
- Site: 34009
-
Madrid, Spain, 28031
- Site: 34004
-
Madrid, Spain, 28046
- Site: 34005
-
Madrid, Spain, 28049
- Site: 34003
-
Mendaro, Spain, 20850
- Site: 34011
-
Murcia, Spain, 30008
- Site: 34013
-
San Sebastian, Spain, 20014
- Site: 34010
-
Sevilla, Spain, 41014
- Site: 34014
-
Valencia, Spain, 46026
- Site: 34012
-
-
-
-
-
Gothenburg, Sweden, 413 45
- Site: 46007
-
Halmstad, Sweden, 302 46
- Site: 46004
-
Karlshamn, Sweden, 37435
- Site: 46005
-
Norrtalje, Sweden, 761 29
- Site: 46003
-
Stockholm, Sweden, 114 46
- Site: 46002
-
Stockholm, Sweden, 14186
- Site: 46001
-
Uppsala, Sweden, 753 35
- Site: 46006
-
-
-
-
-
Frauenfeld, Switzerland, 8501
- Site: 41001
-
Zurich, Switzerland, 8001
- Site: 41003
-
-
-
-
-
Ankara, Turkey, 06500
- Site: 90005
-
Ankara, Turkey, 6100
- Site: 90003
-
Denizli, Turkey, 20070
- Site: 90011
-
Diyarbakir, Turkey, 21080
- Site: 90007
-
Istanbul, Turkey
- Site: 90004
-
Izmir, Turkey, 35100
- Site: 90001
-
Izmir, Turkey, 35340
- Site: 90008
-
Manisa, Turkey, 45010
- Site: 90009
-
Sivas, Turkey, 58140
- Site: 90010
-
-
-
-
-
Chernivtsi, Ukraine, 58000
- Site: 38007
-
Dnepropetrovsk, Ukraine, 49005
- Site: 38004
-
Kharkov, Ukraine, 61057
- Site: 38001
-
Kiev, Ukraine, 2000
- Site: 38002
-
Lviv, Ukraine, 79044
- Site: 38003
-
-
-
-
-
Aberdeen, United Kingdom, AB25 2ZN
- Site: 44027
-
Birmingham, United Kingdom, B15 2TG
- Site: 44029
-
Cambridge, United Kingdom, CB2 2QQ
- Site: 44025
-
Chichester, United Kingdom, PO19 4SE
- Site: 44030
-
Croydon, United Kingdom, CR7 7YE
- Site: 44028
-
Devon, United Kingdom, TQ2 7AA
- Site: 44003
-
Edgbaston, United Kingdom, B15 2TH
- Site: 44001
-
Glasgow, United Kingdom, G11 6NT
- Site: 44011
-
Harrow, United Kingdom, HA 3UJ
- Site: 44023
-
Kent, United Kingdom, ME7 5NY
- Site: 44006
-
Leeds, United Kingdom, LS 9TF
- Site: 44012
-
Leicester, United Kingdom, LE5 4PW
- Site: 44019
-
Liverpool, United Kingdom, L8 7SS
- Site: 44008
-
London, United Kingdom, SW17 0QT
- Site: 44010
-
London, United Kingdom, W2 1NY
- Site: 44017
-
Newcastle upon Tyne, United Kingdom, NE7 7DN
- Site: 44013
-
Northwood, United Kingdom, HA6 2RN
- Site: 44022
-
Nottingham, United Kingdom, NG5 1PB
- Site: 44021
-
Plymouth, United Kingdom, PL6 8DH
- Site: 44009
-
Reading, United Kingdom, RG1 5AN
- Site: 44007
-
Sheffield, United Kingdom, S10 2JF
- Site: 44005
-
Southampton, United Kingdom, SO16 5YA
- Site: 44020
-
Taunton, United Kingdom, TA1 5DA
- Site: 44026
-
West Yorkshire, United Kingdom, BD9 6RJ
- Site: 44024
-
West Yorkshire, United Kingdom, WF8 1PL
- Site: 44002
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is willing and able to complete the micturition diary and questionnaires correctly
- Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
- Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit
Exclusion Criteria:
- Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control
- Subject has neurogenic bladder
- 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 a cough provocation test)
- Subject has an indwelling catheter or practices intermittent self-catheterization
- Subject has diabetic neuropathy
- Subject has 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
- Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated
- The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
- Subject receives 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 has moderate to severe hepatic impairment
- Subject has severe renal impairment or end stage renal disease
- Subject has severe uncontrolled hypertension
- Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval
- Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients
- Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
- Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
- Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
- Subject's last antimuscarinic treatment was solifenacin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mirabegron 50 mg
Participants who received mirabegron 50 mg once daily for 12 weeks.
|
oral tablet
Other Names:
|
ACTIVE_COMPARATOR: Solifenacin 5 mg
Participants who received solifenacin 5 mg once daily for 12 weeks.
|
oral tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline and final visit (up to Week 12)
|
A micturition is any voluntary urination (excluding incontinence only episodes).
The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
|
Baseline and final visit (up to Week 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
|
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake.
The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).
|
From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
|
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline and Week 4, Week 8, Week 12
|
Baseline and Week 4, Week 8, Week 12
|
|
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Time Frame: Week 4, Week 8, Week 12
|
An incontinence episode is any involuntary leakage of urine.
The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
|
Week 4, Week 8, Week 12
|
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Time Frame: Baseline and Week 4, Week 8, Week 12
|
An incontinence episode is any involuntary leakage of urine.
The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
|
Baseline and Week 4, Week 8, Week 12
|
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Time Frame: Week 4, Week 8, Week 12
|
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency.
The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
|
Week 4, Week 8, Week 12
|
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Time Frame: Baseline and Week 4, Week 8, Week 12
|
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency.
The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
|
Baseline and Week 4, Week 8, Week 12
|
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Time Frame: Baseline and Week 4, Week 8, Week 12
|
An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale.
The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
|
Baseline and Week 4, Week 8, Week 12
|
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
Time Frame: Baseline and Week 4, Week 8, Week 12
|
Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.
|
Baseline and Week 4, Week 8, Week 12
|
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Time Frame: Week 4, Week 8, Week 12
|
The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
|
Week 4, Week 8, Week 12
|
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
Time Frame: Baseline and Week 4, Week 8 , Week 12
|
The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
|
Baseline and Week 4, Week 8 , Week 12
|
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Time Frame: Week 4, Week 8, Week 12
|
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake).
The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
|
Week 4, Week 8, Week 12
|
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
Time Frame: Baseline and Week 4, Week 8, Week 12
|
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake).
The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
|
Baseline and Week 4, Week 8, Week 12
|
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
Time Frame: Week 4, Week 8, Week 12
|
A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0.
|
Week 4, Week 8, Week 12
|
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
Time Frame: Week 4, Week 8, Week 12
|
A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.
|
Week 4, Week 8, Week 12
|
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
Time Frame: Week 4, Week 8, Week 12
|
A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.
|
Week 4, Week 8, Week 12
|
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
Time Frame: Baseline and Week 4
|
The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 4
|
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 4
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 4
|
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 4
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 4
|
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 4
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 4
|
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 4
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 4
|
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 8
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 8
|
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 8
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 8
|
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 8
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 8
|
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 8
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 8
|
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 8
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 8
|
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 12
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 12
|
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 12
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 12
|
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 12
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 12
|
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 12
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 12
|
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and Week 12
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and Week 12
|
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and final visit (up to Week 12)
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and final visit (up to Week 12)
|
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and final visit (up to Week 12)
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and final visit (up to Week 12)
|
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and final visit (up to Week 12)
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and final visit (up to Week 12)
|
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and final visit (up to Week 12)
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and final visit (up to Week 12)
|
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
Time Frame: Baseline and final visit (up to Week 12)
|
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome.
It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).
|
Baseline and final visit (up to Week 12)
|
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Time Frame: Baseline and Week 4, Week 8, Week 12
|
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL).
The symptom bother portion consists of 8 items, scored from 1 to 6.
The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity).
A negative change from baseline indicates an improvement.
|
Baseline and Week 4, Week 8, Week 12
|
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q
Time Frame: Baseline and Week 4, Week 8, Week 12
|
The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL).
The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction).
The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life.
A positive change from baseline indicates an improvement.
|
Baseline and Week 4, Week 8, Week 12
|
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)
Time Frame: Baseline and Week 4, Week 8, Week 12
|
The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition.
Participants assessed their bladder condition using a 6-point categorical scale: 1.
Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
|
Baseline and Week 4, Week 8, Week 12
|
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)
Time Frame: Baseline and Week 12
|
The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question "Are you satisfied with your treatment?"
and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).
|
Baseline and Week 12
|
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale
Time Frame: Baseline and Week 12
|
The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question "How satisfied were you with your treatment?"
with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).
|
Baseline and Week 12
|
Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit
Time Frame: Baseline to Week 12
|
A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.
|
Baseline to Week 12
|
Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit
Time Frame: Baseline to Week 12
|
A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.
|
Baseline to Week 12
|
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12
Time Frame: Baseline to Week 12
|
A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.
|
Baseline to Week 12
|
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit
Time Frame: Baseline to final visit (up to Week 12)
|
A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.
|
Baseline to final visit (up to Week 12)
|
Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit
Time Frame: Baseline to Week 12
|
A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.
|
Baseline to Week 12
|
Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit
Time Frame: Baseline to Week 12
|
A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.
|
Baseline to Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 12, 2012
Primary Completion (ACTUAL)
April 24, 2013
Study Completion (ACTUAL)
April 24, 2013
Study Registration Dates
First Submitted
July 9, 2012
First Submitted That Met QC Criteria
July 9, 2012
First Posted (ESTIMATE)
July 11, 2012
Study Record Updates
Last Update Posted (ACTUAL)
December 18, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Urologic Diseases
- Urinary Bladder Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-3 Receptor Agonists
- Mirabegron
- Solifenacin Succinate
Other Study ID Numbers
- 178-EC-001
- 2011-005713-37 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urologic Diseases
-
University Hospital, GhentCompletedSurgery | Bladder Cancer | Urologic CancerBelgium
-
Chang Gung Memorial HospitalCompleted
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; Chang Gung Memorial Hospital; Kaohsiung... and other collaboratorsRecruiting
-
Diskapi Yildirim Beyazit Education and Research...Unknown
-
Fundación Pública Andaluza para la gestión de la...RecruitingSurgery | Anesthesia | Urologic CancerSpain
-
IRCCS San RaffaeleRecruitingUrologic Diseases | Infertility | Urologic CancerItaly
-
Changhai HospitalUTC Therapeutics Inc.RecruitingCD70-positive Advanced Urologic NeoplasmsChina
-
Yonsei UniversityCompletedPediatric Urologic SurgeriesKorea, Republic of
-
Yonsei UniversityCompletedElective Urologic SurgeriesKorea, Republic of
-
Kasr El Aini HospitalUnknownUrologic Surgical ProceduresEgypt
Clinical Trials on Mirabegron
-
The Affiliated Ganzhou Hospital of Nanchang UniversityActive, not recruiting
-
Astellas Pharma IncCompletedHealthy Subjects | Plasma Concentration of MirabegronJapan
-
Thomas Jefferson UniversityAstellas Pharma IncTerminatedAchalasiaUnited States
-
Astellas Pharma IncCompletedHealthy Subjects | Bioavailability | Pharmacokinetics of MirabegronNetherlands
-
Cedars-Sinai Medical CenterRecruitingSyncope | Postural Orthostatic Tachycardia Syndrome | Chronic Orthostatic IntoleranceUnited States
-
Far Eastern Memorial HospitalRecruitingOveractive Bladder SyndromeTaiwan
-
Far Eastern Memorial HospitalRecruitingFemale Patients With Overactive Bladder SyndromeTaiwan
-
Astellas Pharma Europe Ltd.CompletedUrologic Diseases | Urinary Bladder Diseases | Urinary Bladder OveractiveUnited States, Armenia, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Lebanon, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slov... and more
-
Peking Union Medical College HospitalNot yet recruiting
-
Astellas Pharma Europe B.V.Completed