A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
NCT ID: NCT02138747
Last Updated: 2020-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
376 participants
INTERVENTIONAL
2014-07-24
2015-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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AB: Mirabegron/Tolterodine ER
In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
Mirabegron
Oral
Tolterodine ER
Oral
BA: Tolterodine ER /Mirabegron
In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
Mirabegron
Oral
Tolterodine ER
Oral
AA: Mirabegron/Mirabegron
In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
Mirabegron
Oral
BB: Tolterodine ER /Tolterodine ER
Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
Tolterodine ER
Oral
Interventions
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Mirabegron
Oral
Tolterodine ER
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Scientific & Medical Affairs, Inc.
Locations
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Site US10002 Urology Centers of Alabama
Homewood, Alabama, United States
Site US10004 Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
Site US10001 Urological Associates of Southern Arizona
Tucson, Arizona, United States
Site US10003 Genesis Research
San Diego, California, United States
Site US10010 Skyline Urology
Sherman Oaks, California, United States
Site US10028 Clinical Research Consulting
Milford, Connecticut, United States
Site US10024 Coastal Connecticut Research, LLC
New London, Connecticut, United States
Site US10033 Eastern Research
Hialeah, Florida, United States
Site US10023 Advanced Clinical Research of Miami
Miami, Florida, United States
Site US10007 Pinellas Urology, Inc
St. Petersburg, Florida, United States
Site US10022 Palm Beach Research Center
West Palm Beach, Florida, United States
Site US10008 The Iowa Clinic PC, Urology
West Des Moines, Iowa, United States
Site US10014 Mid Atlantic Clinical Research
Greenbelt, Maryland, United States
Site US10005 Boston Clinical Trials
Boston, Massachusetts, United States
Site US10021 AccuMed Research Associates
Garden City, New York, United States
Site US10013 Advanced Urology Centers of New York
Plainview, New York, United States
Site US10020 Upstate Clinical Research Associates LLC
Williamsville, New York, United States
Site US10017 The Jackson Clinic
Jackson, Tennessee, United States
Site US10057 Practice Research Organization
Dallas, Texas, United States
Site US10035 Millennium Clinical Research Center
Arlington, Virginia, United States
Site US10032 Clinical Research and Consulting Center, LLC
Fairfax, Virginia, United States
Site US10034 Health Research of Hampton Roads Inc
Newport News, Virginia, United States
Site CA15012 Glover Medical Clinic
Langley, British Columbia, Canada
Site CA15008 Silverado Research
Victoria, British Columbia, Canada
Site CA15003 The Male/Female Health & Research Centre
Barrie, Ontario, Canada
Site CA15001 Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, Canada
Site CA15011 Scisco Clinical Research
Cornwall, Ontario, Canada
Site CA15002 RechercheGCP Research
Granby, Quebec, Canada
Site CA15007 RechercheGCP Research
Montreal, Quebec, Canada
Site CA15005 CHUS - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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178-MA-1001
Identifier Type: -
Identifier Source: org_study_id
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