A Study to Evaluate Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)

Condition(s) targeted: Overactive Bladder (OAB)

Intervention: Myrbetriq (Drug); Detrol LA (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Astellas Pharma Global Development, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Scientific & Medical Affairs, Inc.

The purpose of this study is to assess tolerability of Myrbetriq compared to Detrol LA in the treatment of subjects with Overactive Bladder (OAB). This study will also assess patient preference, safety and tolerability of Myrbetriq and Detrol LA in subjects with symptoms of OAB as well as the impact of treatment on micturition frequency and incontinence episodes.

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Patient tolerability assessed by the Tolerability Scale of the Overactive Bladder-satisfaction (OAB-S) questionnaire

Secondary outcome:

Patient preference from a 5-point scale

Scales of the OAB-S questionnaire

Change from baseline in number of incontinence episodes per 24 hours

Change from baseline in number of micturitions per 24 hours

Safety profile assessed by adverse events (AE) and vital signs

Safety profile assessed by laboratory parameters (serum chemistry and urinalysis)

Detailed description: The study will comprise of two double-blind treatment periods with a wash-out period in between.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is willing and able to complete the micturition diary and questionnaires

correctly.

- Subject has symptoms of OAB (urinary frequency and urgency with or without

incontinence) for greater than or equal to 3 months prior to Screening.

- Subject must be treatment-naïve to pharmaceutical agents for OAB.

- Female subject must not donate ova starting at Screening and throughout the study

period, and for 30 days after the final study drug administration.

- Male subject must not donate sperm starting at Screening and throughout the study

period and for at least 30 days after final study drug administration.

- Subject 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:

- Subject continues to meet all inclusion criteria of Visit 1.

- Subject must experience at least 3 episodes of urgency (grade 3 or 4) during the

3 day micturition diary.

- Subject must experience an average of greater than or equal to 8

micturitions/day on the 3 day micturition diary Exclusion Criteria:

- Female subject who is lactating or is intending to breastfeed during the study period

and for 30 days after the final study visit.

- The subject has clinically significant bladder outlet obstruction (BOO) posing a risk

of urinary retention.

- Subject has significant stress incontinence or mixed stress/urgency incontinence

where stress is the predominant factor.

- Subject has evidence of Urinary Tract Infection (UTI) (urine culture greater than

100,000 cfu/mL) as assessed at Screening (Visit 1). The subject can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).

- Subject 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).

- Subject has an indwelling catheter or practices intermittent self-catheterization.

- Subject 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.

- Subject 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.

- Subject has received intravesical injection in the past 12 months with botulinum

toxin, resiniferatoxin, or capsaicin.

- Subject has received invasive treatment including electro-stimulation therapy.

- Subject is receiving a bladder training program or pelvic floor exercises which

started or has changed less than 30 days prior to Screening.

- Subject has hepatic impairment defined as Child-Pugh Class A, B or C.

- Subject has severe renal impairment defined as creatinine clearance less than 30

mL/min. A subject with End Stage Renal Disease or undergoing dialysis is also not a candidate for the study.

- Subject 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.

- Subject 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.

- Subject 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.

- Subject has a hypersensitivity to any components of Myrbetriq (mirabegron), other

β-AR agonists, tolterodine or other antimuscarinic agents, or any of the inactive ingredients.

- Subject has been treated with an experimental device within 30 days or received an

investigational agent within 30 days prior to Screening.

- Subject 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.

- Subject with current history of alcohol and/or drug abuse.

- Subject 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):

- Subject fulfills any exclusion criteria at Visit 1.

Urology Centers of Alabama, Homewood, Alabama 35209, United States

Urological Associates of Southern Arizona, Tucson, Arizona 85715, United States

Glover Medical Clinic, Langley, British Columbia V3A 4H9, Canada

Silverado Research Inc., Victoria, British Columbia V8T 2C1, Canada

Genesis Research Center, San Diego, California 92123, United States

Clinical Research Consulting LLC, Milford, Connecticut 06460, United States

Coastal Connecticut Research LLC, New London, Connecticut 06320, United States

Eastern Research, Hialeah, Florida 33013, United States

Advanced Clinical Research of Miami, Miami, Florida 33155, United States

Pinellas Urology Inc, Saint Petersburg, Florida 33710, United States

Palm Beach Research, West Palm Beach, Florida 33409, United States

Iowa Clinic, West Des Moines, Iowa 50266, United States

Mid Atlantic Urology Associates, LLC, Greenbelt, Maryland 20770, United States

Boston Clinical Trials Inc, Boston, Massachusetts 02131, United States

Accumed Research Associates, Garden City, New York 11530-1664, United States

Advanced Urology Centers of New York-Bethpage, Clinical Research Division, Plainview, New York 11803, United States

Upstate Clinical Research Associates LLC, Williamsville, New York 14221, United States

The Male/Female Health and Research Centre, Barrie, Ontario L4M 7G1, Canada

Jonathan Giddens Medicine Professional Corp., Brampton, Ontario L6T 4S5, Canada

Scisco Clinical Research, Cornwall, Ontario K6H 4M4, Canada

Recherches Cliniques Theradev, Granby, Quebec J2G 8Z9, Canada

Recherche GCP Research 4234111 Canada Inc, Montreal, Quebec H2R 1V6, Canada

Centre Hospitalier Universitaire de Sherbrooke CHUS, Sherbrooke, Quebec J1H 5N4, Canada

Practice Research Organization, Inc., Dallas, Texas 75230, United States

Millennium Clinical Research Center, Arlington, Virginia 22203, United States

Clinical Research and Consulting Center, LLC, Fairfax, Virginia 22030, United States

Health Research of Hampton Roads Inc (hrhr), Newport News, Virginia 23606, United States

Starting date: July 2014
Last updated: July 1, 2015