A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
PREFER
A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)
1 other identifier
interventional
376
2 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2014
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
July 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2015
CompletedResults Posted
Study results publicly available
February 14, 2017
CompletedFebruary 26, 2020
February 1, 2020
1.3 years
May 13, 2014
October 19, 2016
February 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)
The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).
Week 8 (End of Period 1) and Week 18 (End of Period 2)
Secondary Outcomes (12)
Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.
Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control
Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control
Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations
Week 8 (End of Period 1) and Week 18 (End of Period 2)
- +7 more secondary outcomes
Study Arms (4)
AB: Mirabegron/Tolterodine ER
EXPERIMENTALIn 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.
BA: Tolterodine ER /Mirabegron
EXPERIMENTALIn 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.
AA: Mirabegron/Mirabegron
EXPERIMENTALIn 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.
BB: Tolterodine ER /Tolterodine ER
EXPERIMENTALParticipants 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.
Interventions
Oral
Oral
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Site US10002 Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Site US10004 Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99503, United States
Site US10001 Urological Associates of Southern Arizona
Tucson, Arizona, 85715, United States
Site US10003 Genesis Research
San Diego, California, 92123, United States
Site US10010 Skyline Urology
Sherman Oaks, California, 91411, United States
Site US10028 Clinical Research Consulting
Milford, Connecticut, 06460, United States
Site US10024 Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Site US10033 Eastern Research
Hialeah, Florida, 33013, United States
Site US10023 Advanced Clinical Research of Miami
Miami, Florida, 33155, United States
Site US10007 Pinellas Urology, Inc
St. Petersburg, Florida, 33710, United States
Site US10022 Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Site US10008 The Iowa Clinic PC, Urology
West Des Moines, Iowa, 50266, United States
Site US10014 Mid Atlantic Clinical Research
Greenbelt, Maryland, 20770, United States
Site US10005 Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Site US10021 AccuMed Research Associates
Garden City, New York, 11530-1664, United States
Site US10013 Advanced Urology Centers of New York
Plainview, New York, 11803, United States
Site US10020 Upstate Clinical Research Associates LLC
Williamsville, New York, 14221, United States
Site US10017 The Jackson Clinic
Jackson, Tennessee, 38305, United States
Site US10057 Practice Research Organization
Dallas, Texas, 75230, United States
Site US10035 Millennium Clinical Research Center
Arlington, Virginia, 22203, United States
Site US10032 Clinical Research and Consulting Center, LLC
Fairfax, Virginia, 22030, United States
Site US10034 Health Research of Hampton Roads Inc
Newport News, Virginia, 23606, United States
Site CA15012 Glover Medical Clinic
Langley, British Columbia, V3A 4H9, Canada
Site CA15008 Silverado Research
Victoria, British Columbia, V8T 2C1, Canada
Site CA15003 The Male/Female Health & Research Centre
Barrie, Ontario, L4M 7G1, Canada
Site CA15001 Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, L6T 4S5, Canada
Site CA15011 Scisco Clinical Research
Cornwall, Ontario, K6H 4M4, Canada
Site CA15002 RechercheGCP Research
Granby, Quebec, J2G 8Z9, Canada
Site CA15007 RechercheGCP Research
Montreal, Quebec, H1M 1B1, Canada
Site CA15005 CHUS - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma US, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Scientific & Medical Affairs, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
July 24, 2014
Primary Completion
October 29, 2015
Study Completion
November 11, 2015
Last Updated
February 26, 2020
Results First Posted
February 14, 2017
Record last verified: 2020-02