Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
PILLAR
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
1 other identifier
interventional
888
2 countries
120
Brief Summary
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2014
Typical duration for phase_4
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedStudy Start
First participant enrolled
October 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2018
CompletedResults Posted
Study results publicly available
February 15, 2019
CompletedNovember 22, 2024
October 1, 2024
3.1 years
August 12, 2014
November 26, 2018
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
Baseline and EOT (up to 12 weeks)
Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.
Baseline and EOT (up to 12 weeks)
Secondary Outcomes (24)
Change From Baseline to EOT in Mean Volume Voided Per Micturition
Baseline and EOT (up to 12 weeks)
Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score
Baseline and EOT (up to 12 weeks)
Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score
Baseline and EOT (up to 12 weeks)
Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)
Baseline and EOT (up to 12 weeks)
Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Baseline and EOT (up to 12 weeks)
- +19 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
Mirabegron
EXPERIMENTALParticipants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
Interventions
Eligibility Criteria
You may qualify if:
- Subject is willing and able to complete the micturition diary and questionnaires correctly.
- Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening.
- Subject agrees not to participate in another interventional study from the time of screening until the final study visit.
- Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary.
- Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day micturition diary.
- Subject must experience an average of greater than or equal to 8 micturitions/day based on the 3-day micturition diary.
You may not qualify if:
- Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled.
- Subject has Post-Void Residual Volume (PVR) greater than 150 mL.
- Subject has neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply.
- Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test.
- Subject has an indwelling catheter or practices intermittent self-catheterization.
- Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the investigator's discretion and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI 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 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; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen).
- Subject resides in a nursing home.
- Subject is likely to enter a hospital or nursing home due to medical instability within the next 6 months in the opinion of the Investigator.
- Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
- Subject has received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation \[PTNS\]).
- Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening.
- Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
- Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, Cockroft-Gault, or MDRD formulae). 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 to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
Site US00066
Huntsville, Alabama, 35801, United States
Site US00148
Mobile, Alabama, 36608, United States
Site US00009
Anchorage, Alaska, 99503, United States
Site US00020
Tucson, Arizona, 85715, United States
Site US00019
Tucson, Arizona, 85745, United States
Site US00063
Little Rock, Arkansas, 72120, United States
Site US00081
Little Rock, Arkansas, 72205, United States
Site US00176
Anaheim, California, 92801, United States
Site US00048
Beverly Hills, California, 90211, United States
Site US00142
Beverly Hills, California, 90212, United States
Site US00150
Hawaiian Gardens, California, 90716, United States
Site US00112
Los Angeles, California, 90017, United States
Site US00034
Los Angeles, California, 90027, United States
Site US00010
Murrieta, California, 92562, United States
Site US00135
San Diego, California, 92117, United States
Site US00139
San Diego, California, 92120, United States
Site US00144
Santa Maria, California, 93454, United States
Site US00083
Stanford, California, 94305, United States
Site US00026
Colorado Springs, Colorado, 80907, United States
Site US00039
Denver, Colorado, 80220, United States
Site US00004
Denver, Colorado, 80239, United States
Site US00040
New London, Connecticut, 06320, United States
Site US00090
Washington D.C., District of Columbia, 20010, United States
Site US00064
Brooksville, Florida, 34601, United States
Site US00080
Coral Gables, Florida, 33134, United States
Site US00002
DeBary, Florida, 32713, United States
Site US00001
DeLand, Florida, 32720, United States
Site US00017
DeLand, Florida, 32720, United States
Site US00018
Edgewater, Florida, 32132, United States
Site US00027
Fleming Island, Florida, 32003, United States
Site US00151
Hialeah, Florida, 33016, United States
Site US00179
Jupiter, Florida, 33458, United States
Site US00057
Kissimmee, Florida, 34744, United States
Site US00076
Lakeland, Florida, 33805, United States
Site US00037
Miami, Florida, 33135, United States
Site US00029
Miami, Florida, 33144, United States
Site US00042
Miami, Florida, 33173, United States
Site US00007
North Miami, Florida, 33161, United States
Site US00021
Pompano Beach, Florida, 33060, United States
Site US00035
Port Orange, Florida, 32129, United States
Site US00075
St. Petersburg, Florida, 33709, United States
Site US00099
Tampa, Florida, 33606, United States
Site US00005
Savannah, Georgia, 31406, United States
Site US00041
Boise, Idaho, 83642, United States
Site US00060
Greenwood, Indiana, 46143, United States
Site US00046
Jeffersonville, Indiana, 47130, United States
Site US00134
West Des Moines, Iowa, 50266, United States
Site US00104
Augusta, Kansas, 67010, United States
Site US00105
Newton, Kansas, 67114, United States
Site US00045
Overland Park, Kansas, 66202, United States
Site US00172
Lake Charles, Louisiana, 70601, United States
Site US00025
Annapolis, Maryland, 21401, United States
Site US00091
Brockton, Massachusetts, 02301, United States
Site US00006
New Bedford, Massachusetts, 02740, United States
Site US00145
Watertown, Massachusetts, 02472, United States
Site US00056
Grand Rapids, Michigan, 49503, United States
Site US00003
Kalamazoo, Michigan, 49009, United States
Site US00093
Saginaw, Michigan, 48604, United States
Site US00024
Edina, Minnesota, 55435, United States
Site US00137
Sartell, Minnesota, 56377, United States
Site US00159
Billings, Montana, 59102, United States
Site US00070
Norfolk, Nebraska, 68701, United States
Site US00014
Las Vegas, Nevada, 89148, United States
Site US00113
East Brunswick, New Jersey, 08816, United States
Site US00111
New Brunswick, New Jersey, 08901, United States
Site US00140
Albuquerque, New Mexico, 87102, United States
Site US00016
Brooklyn, New York, 11215, United States
Site US00043
Williamsville, New York, 14221, United States
Site US00153
Charlotte, North Carolina, 28209, United States
Site US00132
Concord, North Carolina, 28025, United States
Site US00122
Greensboro, North Carolina, 27403, United States
Site US00161
Raleigh, North Carolina, 27609, United States
Site US00165
Wilmington, North Carolina, 28401, United States
Site US00166
Winston-Salem, North Carolina, 27103, United States
Site US00085
Fargo, North Dakota, 58103, United States
Site US00067
Akron, Ohio, 44313, United States
Site US00050
Cincinnati, Ohio, 45249, United States
Site US00095
Cleveland, Ohio, 44109, United States
Site US00084
Mentor, Ohio, 44094, United States
Site US00015
Middleburg Heights, Ohio, 44130, United States
Site US00102
Norman, Oklahoma, 73069, United States
Site US00103
Portland, Oregon, 97239, United States
Site US00180
Pittsburgh, Pennsylvania, 15236, United States
Site US00082
Moncks Corner, South Carolina, 29461, United States
Site US00162
Mt. Pleasant, South Carolina, 29464, United States
Site US00032
Bristol, Tennessee, 37620, United States
Site US00154
Chattanooga, Tennessee, 37421, United States
Site US00053
Franklin, Tennessee, 37064, United States
Site US00052
Nashville, Tennessee, 37211, United States
Site US00175
Austin, Texas, 78705, United States
Site US00131
Houston, Texas, 77030, United States
Site US00174
Hurst, Texas, 76054, United States
Site US00068
San Antonio, Texas, 78209, United States
Site US00071
San Antonio, Texas, 78229, United States
Site US00100
San Antonio, Texas, 78229, United States
Site US00044
Salt Lake City, Utah, 84107, United States
Site US00036
Salt Lake City, Utah, 84124, United States
Site US00023
West Jordan, Utah, 84088, United States
Site US00170
Newport News, Virginia, 23606, United States
Site US00086
Norfolk, Virginia, 23502, United States
Site US00167
Seattle, Washington, 98150, United States
Site US00098
Tacoma, Washington, 98405, United States
Site US00062
Madison, Wisconsin, 53715, United States
Site CA00130
Edmonton, Alberta, T5G 0B7, Canada
Site CA00074
Vancouver, British Columbia, V6J1S3, Canada
Site CA00155
Brampton, Ontario, L6T 4S5, Canada
Site CA00123
Corunna, Ontario, N0N1G0, Canada
Site CA00169
Greater Sudbury, Ontario, P3E 3Z9, Canada
Site CA00126
Hamilton, Ontario, L8N 4A6, Canada
Site CA00118
London, Ontario, N6A 4V2, Canada
Site CA00116
Sarnia, Ontario, N7T4X3, Canada
Site CA00168
Toronto, Ontario, M4S 1Y2, Canada
Site CA00164
Lévis, Quebec, G6W 0M6, Canada
Site CA00158
Montreal, Quebec, H2Y 1S1, Canada
Site CA00073
Point Claire, Quebec, H9R4S3, Canada
Site CA00106
Point Claire, Quebec, H9R4S3, Canada
Site CA00156
Sherbrooke, Quebec, J1H 1Z1, Canada
Site CA00061
Sherbrooke, Quebec, J1H5N2, Canada
Site CA00129
Québec, G1S2L6, Canada
Site CA00160
Québec, G1X 0B6, Canada
Related Publications (2)
Herschorn S, Staskin D, Schermer CR, Kristy RM, Wagg A. Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients >/= 65 years with Overactive Bladder-Wet. Drugs Aging. 2020 Sep;37(9):665-676. doi: 10.1007/s40266-020-00783-w.
PMID: 32725584DERIVEDGriebling TL, Campbell NL, Mangel J, Staskin D, Herschorn S, Elsouda D, Schermer CR. Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR). BMC Geriatr. 2020 Mar 18;20(1):109. doi: 10.1186/s12877-020-1474-7.
PMID: 32183741DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Participants from one site were excluded from the FAS-I and SAF due to critical findings observed during a GCP audit of the site.
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc., Medical Affairs, Americas
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 13, 2014
Study Start
October 7, 2014
Primary Completion
November 29, 2017
Study Completion
January 2, 2018
Last Updated
November 22, 2024
Results First Posted
February 15, 2019
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.