Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
SCORPIO
A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder
2 other identifiers
interventional
2,336
28 countries
202
Brief Summary
The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2008
Shorter than P25 for phase_3
202 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 28, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2009
CompletedResults Posted
Study results publicly available
October 17, 2012
CompletedNovember 20, 2024
October 1, 2024
11 months
May 29, 2008
July 17, 2012
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Baseline and Week 12 (final visit)
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Baseline and Week 12
Secondary Outcomes (29)
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
Baseline and Week 12
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Week 4
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
Baseline and Week 4
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Weeks 8 and 12
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
Baseline and Weeks 8 and 12
- +24 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
Mirabegron 50 mg
EXPERIMENTALParticipants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
Mirabegron 100 mg
EXPERIMENTALParticipants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
Tolterodine SR 4 mg
ACTIVE COMPARATORParticipants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Interventions
Matching tolterodine placebo capsules.
Eligibility Criteria
You may qualify if:
- Subject is willing and able to complete the micturition diary and questionnaires correctly
- Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
- Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
- Subject 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:
- Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
- Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- 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 receives non-drug treatment including electro-stimulation therapy
- Subject has severe hypertension
- Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
- Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
- Subject had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
- Subject has serum creatinine \>150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) \> 3x ULN
- Subject has a clinically significant abnormal electrocardiogram (ECG)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (218)
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Auchenflower, Australia
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Clayton, Australia
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Kogarah, Australia
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Randwick, Australia
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Woolloongabba, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Minsk, 220036, Belarus
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Minsk, 220119, Belarus
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Minsk, 223041, Belarus
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Antwerp, 2020, Belgium
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Antwerp, 2030, Belgium
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Brussels, 1070, Belgium
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Brussels, 1090, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leper, 8900, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Sint-Truiden, 3800, Belgium
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Pleven, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Brno, 60200, Czechia
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Mělník, 27601, Czechia
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Olomouc, 77200, Czechia
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Ostrava-Poruba, 70853, Czechia
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Pilsen, 30599, Czechia
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Prague, 12851, Czechia
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Prague, 14056, Czechia
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Prague, 18081, Czechia
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Štětí, 41108, Czechia
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Ústí nad Labem, 40001, Czechia
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Aalborg, 9100, Denmark
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Aarhus, 8200, Denmark
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Glostrup Municipality, 2600, Denmark
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Roskilde, Denmark
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Helsinki, 00029, Finland
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Oulu, 90220, Finland
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Tampere, 33521, Finland
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Turku, 20100, Finland
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Bordeaux, 33076, France
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Colmar, 68024, France
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Marseille, 13274, France
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Marseille, 13285, France
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Mulhouse, 68070, France
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Nantes, 45035, France
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Nîmes, 30029, France
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Orléans, 45067, France
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Paris, 75020, France
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Paris, 75571, France
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Rouen, 76031, France
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Saint-Priest-en-Jarez, 42055, France
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Strasbourg, 67000, France
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Toulouse, 31059, France
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Aichach, 86551, Germany
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Bad Ems, 56130, Germany
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Bautzen, 02625, Germany
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Berlin, 13347, Germany
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Duisburg, 47051, Germany
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Eisleben Lutherstadt, 06295, Germany
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Frankfurt, 65933, Germany
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Ganderkesee, 27777, Germany
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Hagenow, 19230, Germany
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Halle, 06132, Germany
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Hamburg, 20253, Germany
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Henningsdorf, 16761, Germany
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Hettstedt, 06333, Germany
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Koblenz, 56068, Germany
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Leipzig, 04105, Germany
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Muenchen-Bogenhausen, 81925, Germany
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Neustadt in Sachsen, 01844, Germany
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Oranienburg, 16151, Germany
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Radebeul, 01445, Germany
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Sangerhausen, 06526, Germany
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Trier, 54290, Germany
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Uetersen, 25436, Germany
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Athens, Greece
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Nikaias-Piraeus, Greece
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Pátrai, Greece
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Thessaloniki, Greece
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Budapest, 1047, Hungary
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Budapest, 1076, Hungary
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Budapest, 1204, Hungary
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Debrecen, 4043, Hungary
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Eger, 3300, Hungary
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Nyíregyháza, 4400, Hungary
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Pápa, Hungary
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Sopron, Hungary
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Szeged, 6725, Hungary
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Szekszárd, 7100, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Veszprém, 8200, Hungary
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Reykjavik, 101, Iceland
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Cork, Ireland
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Dublin, Ireland
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Mullingar, Ireland
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Tralee, Ireland
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Bari, 70124, Italy
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Catanzaro, 88100, Italy
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Florence, 50139, Italy
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Florence, 59129, Italy
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Genoa, 16128, Italy
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Latina, 04100, Italy
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Magenta, 20013, Italy
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Milan, 20142, Italy
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Milan, 20153, Italy
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Modena, 41100, Italy
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Naples, 80131, Italy
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Perugia, 06122, Italy
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Teramo, 64100, Italy
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Treviglio, 24047, Italy
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Varese, 21100, Italy
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Liepāja, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Vilnius, Lithuania
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Amsterdam, 1105 AZ, Netherlands
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Apeldoorn, 7334 DZ, Netherlands
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Apeldoorn, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Enschede, 7511 JX, Netherlands
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Leiden, 2334 CK, Netherlands
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Maastricht, 6229 HX, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Sneek, 8600 BA, Netherlands
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Tilburg, 5022 GC, Netherlands
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Winterswijk, 7101 BN, Netherlands
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Bergen, 5021, Norway
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Drammen, 3016, Norway
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Hamar, 2317, Norway
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Oslo, 0257, Norway
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Tønsberg, 3103, Norway
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Bialystok, 15-278, Poland
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Chorzów, 41-500, Poland
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Lodz, 93-338, Poland
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Lodz, 93-513, Poland
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Lublin, 20-954, Poland
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Warsaw, 00-846, Poland
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Warsaw, 02-005, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 50-556, Poland
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Amadora, 2700, Portugal
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Porto, 4099-005, Portugal
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Tomar, 2304-909, Portugal
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Viana do Castelo, 4900-858, Portugal
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Bucharest, 22328, Romania
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Bucharest, Romania
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Lasi, Romania
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Oradea, Romania
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Timișoara, Romania
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Moscow, 101000, Russia
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Moscow, 105425, Russia
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Moscow, 111020, Russia
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Moscow, 111123, Russia
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Moscow, 115516, Russia
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Moscow, 117049, Russia
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Moscow, 117815, Russia
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Moscow, 119435, Russia
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Moscow, 123836, Russia
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Moscow, 125206, Russia
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Saint Petersburg, 197089, Russia
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Saint Petersburg, 198013, Russia
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Martin, 03659, Slovakia
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Poprad, 05801, Slovakia
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Skalica, 90982, Slovakia
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Trenčín, 91101, Slovakia
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Žilina, 01207, Slovakia
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Bloemfontein, South Africa
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Hatfield, South Africa
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Lyttelton, South Africa
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Paarl, South Africa
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Pietermaritzburg, South Africa
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Barcelona, 08020, Spain
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Bilbao, 48013, Spain
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Esplugues de Llobregat-Barcelo, 08950, Spain
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Fuenlabrada, 28942, Spain
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Getafe, 28905, Spain
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Madrid, 28016, Spain
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Madrid, 28046, Spain
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Madrid, Spain
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Mataró, 8304, Spain
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Miranda de Ebro, 09200, Spain
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Palma de Mallorca, 07014, Spain
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Seville, 41013, Spain
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Toledo, 45071, Spain
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Valencia, 46010, Spain
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Villarreal de Huerva, 12540, Spain
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Borås, 50182, Sweden
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Helsingborg, 25187, Sweden
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Örebro, 70185, Sweden
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Skövde, 54130, Sweden
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Stockholm, 11883, Sweden
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Stockholm, 14186, Sweden
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Stockholm, 17176, Sweden
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Stockholm, 18288, Sweden
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Umeå, 90185, Sweden
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Uppsala, 75185, Sweden
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Frauenfeld, 8501, Switzerland
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Lucerne, 6000, Switzerland
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Kiev, 01023, Ukraine
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Kiev, 04053, Ukraine
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Birmingham, B15 2TG, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Croydon, CR7 7YE, United Kingdom
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Liverpool, L22 OLG, United Kingdom
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London, SE5 9RS, United Kingdom
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London, W2 2YP, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Reading, RG1 5AN, United Kingdom
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Reading, RG2 7AG, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Swansea, SA6 6NL, United Kingdom
Related Publications (3)
Khullar V, Amarenco G, Angulo JC, Cambronero J, Hoye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.
PMID: 23182126BACKGROUNDStoniute 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: 37160401DERIVEDDesroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.
PMID: 24246044DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Medical Science
- Organization
- Astellas Pharma Europe B.V.
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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 29, 2008
First Posted
June 3, 2008
Study Start
April 28, 2008
Primary Completion
March 24, 2009
Study Completion
March 24, 2009
Last Updated
November 20, 2024
Results First Posted
October 17, 2012
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/.