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Overactive Bladder (OAB)Phase 4PREFERNCT02138747

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

A Phase 4 study testing Mirabegron and Tolterodine ER in people with Overactive Bladder (OAB), run by Astellas Pharma Global Development, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder (OAB)
What is being tested?
Mirabegron and Tolterodine ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
30 sitesin 2 countries
Study dates
24 Jul 2014to 11 Nov 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.
  • Participant fulfills any exclusion criteria at Visit 1.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States22 sites

  • Site US10004 Alaska Clinical Research Center, LLC

    Anchorage, Alaska, 99503

  • Site US10035 Millennium Clinical Research Center

    Arlington, Virginia, 22203

  • Site US10005 Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Site US10057 Practice Research Organization

    Dallas, Texas, 75230

  • Site US10032 Clinical Research and Consulting Center, LLC

    Fairfax, Virginia, 22030

  • Site US10021 AccuMed Research Associates

    Garden City, New York, 11530-1664

  • Site US10014 Mid Atlantic Clinical Research

    Greenbelt, Maryland, 20770

  • Site US10033 Eastern Research

    Hialeah, Florida, 33013

  • Site US10002 Urology Centers of Alabama

    Homewood, Alabama, 35209

  • Site US10017 The Jackson Clinic

    Jackson, Tennessee, 38305

  • Site US10023 Advanced Clinical Research of Miami

    Miami, Florida, 33155

  • Site US10028 Clinical Research Consulting

    Milford, Connecticut, 06460

  • Site US10024 Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Site US10034 Health Research of Hampton Roads Inc

    Newport News, Virginia, 23606

  • Site US10013 Advanced Urology Centers of New York

    Plainview, New York, 11803

  • Site US10003 Genesis Research

    San Diego, California, 92123

  • Site US10010 Skyline Urology

    Sherman Oaks, California, 91411

  • Site US10007 Pinellas Urology, Inc

    St. Petersburg, Florida, 33710

  • Site US10001 Urological Associates of Southern Arizona

    Tucson, Arizona, 85715

  • Site US10008 The Iowa Clinic PC, Urology

    West Des Moines, Iowa, 50266

  • Site US10022 Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Site US10020 Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

Other trials in United States

Canada8 sites

  • Site CA15003 The Male/Female Health & Research Centre

    Barrie, Ontario, L4M 7G1

  • Site CA15001 Jonathan Giddens Medicine Professional Corporation

    Brampton, Ontario, L6T 4S5

  • Site CA15011 Scisco Clinical Research

    Cornwall, Ontario, K6H 4M4

  • Site CA15002 RechercheGCP Research

    Granby, Quebec, J2G 8Z9

  • Site CA15012 Glover Medical Clinic

    Langley, British Columbia, V3A 4H9

  • Site CA15007 RechercheGCP Research

    Montreal, Quebec, H1M 1B1

  • Site CA15005 CHUS - Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Site CA15008 Silverado Research

    Victoria, British Columbia, V8T 2C1

Other trials in Canada

About this study

Official title: 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)

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.

Read the detailed description

The study consisted of two double-blind treatment periods with a wash-out period in between.

Being tested
Mirabegron, Tolterodine ER
Keywords
Overactive bladder (OAB), tolterodine ER, mirabegron
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirabegronDrug

    Also called Myrbetriq, YM178

    Oral

  • Tolterodine ERDrug

    Also called Detrol LA

    Oral

Study groups in NCT02138747
Study groupRoleWhat they receive
AB: Mirabegron/Tolterodine ERExperimentalIn 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.
Receives: Drug: Mirabegron; Drug: Tolterodine ER
BA: Tolterodine ER /MirabegronExperimentalIn 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.
Receives: Drug: Mirabegron; Drug: Tolterodine ER
AA: Mirabegron/MirabegronExperimentalIn 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.
Receives: Drug: Mirabegron
BB: Tolterodine ER /Tolterodine ERExperimentalParticipants 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.
Receives: Drug: Tolterodine ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

Secondary outcomes (12)

  1. 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.

    Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 ("strong preference for period 1," "mild preference for period 1," "no preference," "mild preference for period 2," "strong preference for period 2"). Participants who selected either a "mild preference" or "strong preference" were considered as having a preference for a specific study drug and participants who selected "no preference" were considered as having no preference for one study drug over the other study drug."

    Measured: Week 18 (End of Period 2)

  2. Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.

    Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  3. Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control

    OAB control was scored from 0 to 100, with higher scores indicating better OAB control.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  4. Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control

    Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  5. Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations

    The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  6. Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB

    Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  7. Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication

    Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  8. Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication

    Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  9. Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication

    Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication.

    Measured: Week 8 (End of Period 1) and Week 18 (End of Period 2)

  10. Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours

    Measured: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)

  11. Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours

    Measured: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)

  12. Number of Participants With Adverse Events

    Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug.

    Measured: Baseline to EOT (Week 18) and follow up (Week 20)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2014 (estimated)
  2. Study start24 Jul 2014
  3. Primary completion29 Oct 2015
  4. Study completion11 Nov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02138747
Sponsor's protocol ID
178-MA-1001
Acronym
PREFER
Status last verified
Feb 2020
First submitted
13 May 2014
Last updated
26 Feb 2020
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mirabegron and Tolterodine ER in people with Overactive Bladder (OAB), run by Astellas Pharma Global Development, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) (time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02138747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.

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