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Astellas Study ID
178-MA-1001

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants with Overactive Bladder (OAB)

Astellas Study ID
178-MA-1001
Clinicaltrials.gov ID
NCT02138747
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.

Additional Study Details

Phase
4
Product
N/A
Product
Mirabegron
Tolterodine ER
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment number
376
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Study documents

Scientific Results Summary
Available Language(s): English
Download Document(s)
Plain Language Summary
Available Language(s): English
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Would you like more information about clinical trial sites that are recruiting participants for A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants with Overactive Bladder (OAB)? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

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    Locations

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    Withdrawn
    Site US10019 Chesapeake Urology Research Associates
    Towson, Maryland, United States, 21204
    Contact Us
    Completed
    Site CA15005 CHUS - Hopital Fleurimont
    Sherbrooke, Quebec, Canada, J1H 5N4
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    Withdrawn
    Site US10016 Suffolk OB/GYN, LLP
    Port Jefferson, New York, United States, 11777
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    Completed
    Site US10035 Millennium Clinical Research Center
    Arlington, Virginia, United States, 22203
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    Completed
    Site US10005 Boston Clinical Trials
    Boston, Massachusetts, United States, 02131
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    Completed
    Site CA15012 Glover Medical Clinic
    Langley, British Columbia, Canada, V3A 4H9
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    Completed
    Site US10033 Eastern Research
    Hialeah, Florida, United States, 33013
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    Completed
    Site US10022 Palm Beach Research Center
    West Palm Beach, Florida, United States, 33409
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    Withdrawn
    Site US10009 North Shore LIJ Health System
    Great Neck, New York, United States, 11021
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    Completed
    Site US10001 Urological Associates of Southern Arizona
    Tucson, Arizona, United States, 85715
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    Completed
    Site US10002 Urology Centers of Alabama
    Homewood, Alabama, United States, 35209
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    Completed
    Site US10010 Skyline Urology
    Sherman Oaks, California, United States, 91411
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    Completed
    Site CA15001 Jonathan Giddens Medicine Professional Corporation
    Brampton, Ontario, Canada, L6T 4S5
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    Completed
    Site CA15002 RechercheGCP Research
    Granby, Quebec, Canada, J2G 8Z9
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    Withdrawn
    Site US10015 Nevada Access To Research and Education Society
    Las Vegas, Nevada, United States, 89106
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    Completed
    Site CA15008 Silverado Research
    Victoria, British Columbia, Canada, V8T 2C1
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    Completed
    Site US10024 Coastal Connecticut Research, LLC
    New London, Connecticut, United States, 06320
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    Completed
    Site US10023 Advanced Clinical Research of Miami
    Miami, Florida, United States, 33155
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    Completed
    Site US10007 Pinellas Urology, Inc
    Saint Petersburg, Florida, United States, 33710
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    Completed
    Site US10057 Practice Research Organization
    Dallas, TX, United States, 75230
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    Completed
    Site US10013 Advanced Urology Centers of New York
    Plainview, New York, United States, 11803
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    Completed
    Site US10008 The Iowa Clinic PC, Urology
    West Des Moines, Iowa, United States, 50266
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    Completed
    Site US10021 AccuMed Research Associates
    Garden City, New York, United States, 11530-1664
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    Completed
    Site US10020 Upstate Clinical Research Associates LLC
    Williamsville, New York, United States, 14221
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    Completed
    Site US10017 The Jackson Clinic
    Jackson, Tennessee, United States, 38305
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    Completed
    Site CA15011 Scisco Clinical Research
    Cornwall, Ontario, Canada, K6H 4M4
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    Completed
    Site US10003 Genesis Research
    San Diego, California, United States, 92123
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    Completed
    Site CA15007 RechercheGCP Research
    Montreal, Quebec, Canada, H1M 1B1
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    Completed
    Site US10034 Health Research of Hampton Roads Inc
    Newport News, Virginia, United States, 23606
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    Completed
    Site US10028 Clinical Research Consulting
    Milford, Connecticut, United States, 06460
    Contact Us
    Completed
    Site CA15003 The Male/Female Health & Research Centre
    Barrie, Ontario, Canada, L4M 7G1
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    Withdrawn
    Site US10006 Skyline Urology
    Torrance, California, United States, 90505
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    Completed
    Site US10004 Alaska Clinical Research Center, LLC
    Anchorage, Alaska, United States, 99503
    Contact Us
    Completed
    Site US10014 Mid Atlantic Clinical Research
    Greenbelt, Maryland, United States, 20770
    Contact Us
    Withdrawn
    Site US10018 Institute for Female Pelvic Medicine
    Allentown, Pennsylvania, United States, 18103
    Contact Us
    Completed
    Site US10032 Clinical Research and Consulting Center, LLC
    Fairfax, Virginia, United States, 22030
    Contact Us
    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Overactive Bladder Disease
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Jul 2014 - Oct 2015
    Additional Study Details
    Inclusion Criteria
    • Participant is willing and able to complete the micturition diary and questionnaires correctly.
    • Participant has symptoms of OAB (urinary frequency and urgency with or without incontinence) for greater than or equal to 3 months prior to Screening.
    • Participant must be treatment-naïve to pharmaceutical agents for OAB.
    • Female participant must not donate ova starting at Screening and throughout the study period, and for 30 days after the final study drug administration.
    • Male participant must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration.
    • Participant agrees not to participate in another interventional study from the time of screening until the final study visit.
    • Inclusion Criteria assessed at Visit 2 (Week 0) based on the 3-day micturition diary:
      • Participant continues to meet all inclusion criteria of Visit 1.
      • Participant must experience at least 3 episodes of urgency (grade 3 or 4) during the 3 day micturition diary.
      • Participant must experience an average of greater than or equal to 8 micturitions/day on the 3 day micturition diary
    MaximizeExclusion Criteria
    • Female participant who is lactating or is intending to breastfeed during the study period and for 30 days after the final study visit.
    • The participant has clinically significant bladder outlet obstruction (BOO) posing a risk of urinary retention.
    • Participant has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor.
    • Participant has evidence of Urinary Tract Infection (UTI) (urine culture greater than 100,000 cfu/mL) as assessed at Screening (Visit 1). The participant can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
    • Participant has a neurological cause for detrusor overactivity (e.g., neurogenic bladder, diabetic neuropathy or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease).
    • Participant has an indwelling catheter or practices intermittent self-catheterization.
    • Participant has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females); or of the lower gastrointestinal tract.
    • Participant has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe colitis ulcerosa, toxic megacolon, myasthenia gravis, polio or any other medical condition which makes the use of anticholinergics contraindicated.
    • Participant has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
    • Participant has received invasive treatment including electro-stimulation therapy.
    • Participant is receiving a bladder training program or pelvic floor exercises which started or has changed less than 30 days prior to Screening.
    • Participant has hepatic impairment defined as Child-Pugh Class A, B or C.
    • Participant has severe renal impairment defined as creatinine clearance less than 30 mL/min. A participant with End Stage Renal Disease or undergoing dialysis is also not a candidate for the study.
    • Participant has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure greater than or equal 180 mmHg and/or diastolic blood pressure greater than or equal 110 mmHg.
    • Participant has evidence of QT prolongation on electrocardiogram (ECG) defined as QTcF greater than 450 msec for males, QTcF greater than 470 msec for females or a known history of QT prolongation.
    • Participant has a serum creatinine greater than 150 µmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or γ-GT greater than 3x ULN and considered clinically significant.
    • Participant has a hypersensitivity to any components of Myrbetriq (mirabegron), other β-AR agonists, tolterodine or other antimuscarinic agents, or any of the inactive ingredients.
    • Participant has been treated with an experimental device within 30 days or received an investigational agent within 30 days prior to Screening.
    • Participant has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
    • Participant with current history of alcohol and/or drug abuse.
    • Participant is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team.
    • Exclusion Criteria assessed at Visit 2 (Week 0):
      • Participant fulfills any exclusion criteria at Visit 1.

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