A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)



Status:Completed
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:July 10, 2013
End Date:November 25, 2014

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms

The purpose of this study was to see if adding a new type of medication recently approved to
treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be
more effective in controlling incontinence than when using the antimuscarinic treatment
alone.


Inclusion Criteria:

- Main Inclusion at Screening:

1. Subject has symptoms of OAB (urinary frequency and urgency with urgency
incontinence) for >= 3 months prior to the screening visit

2. Subject is willing and able to complete the micturition diary and questionnaires
correctly, including collection and measurement of urine output for 3 days prior
to each visit;

3. Subject has symptoms of "wet" OAB (urinary frequency and urgency with
incontinence or mixed incontinence with predominant urgency incontinence), and
reports an average of at least 2 incontinence episodes per day.

- Main Inclusion at Run-in (Visit 2):

1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with
or without incontinence per 24-hour period during the 3-day micturition diary
period.

2. Subject experiences on average at least 2 incontinence episodes per 24-hour
period during the 3-day micturition diary period.

3. Subject experiences on average at least 8 micturitions (excluding incontinence
episodes) per 24-hour period during the 3-day micturition diary period.

- Main Inclusion at Randomization (Visit 3):

1. Subject experiences at least 1 incontinence episode during the 3-day micturition
diary period and wishes to increase their treatment for OAB symptoms.

Exclusion Criteria:

- Main Exclusion at Screening:

1. Subject in the opinion of the investigator has clinically significant Bladder
Outlet Obstruction (BOO).

2. Subject has significant Post-void residual (PVR) volume (PVR > 150 ml).

3. Subject has significant stress incontinence or mixed stress/urgency incontinence
where stress is the predominant factor as determined by the investigator

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

5. Subject has evidence of a UTI.

6. Subject has chronic inflammation such as interstitial cystitis, bladder stones,
previous pelvic radiation therapy, or previous or current malignant disease of
the pelvic organs

7. Subject has moderate to severe hepatic impairment

8. Subject has severe renal impairment or End Stage Renal disease

9. Subject has a clinically significant abnormal Electrocardiogram (ECG)

10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin
cancer) within the last 5 years prior to screening.

11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at
risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).

12. Subject has received intravesical treatment in the past 12 months with e.g.,
botulinum toxin, resiniferatoxin, capsaicin.

13. Subject has severe uncontrolled hypertension, which is defined as a sitting
average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood
pressure ≥ 110 mmHg.

- Main Exclusion at Randomization (visit 3):

1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence
episodes are recorded in the 3 day diary administered for 3 days prior to Visit
3).

2. Subject does not desire an increase in study medication.

3. Subject has an average total daily urine volume > 3000ml as recorded in the
micturition diary.

4. Subject has severe uncontrolled hypertension, which is defined as a sitting
average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood
pressure ≥ 110 mmHg.

5. Subject has a clinically significant abnormal ECG
We found this trial at
37
sites
Watertown, Massachusetts 02472
2571
mi
from 91732
Watertown, MA
Click here to add this to my saved trials
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
567
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
2135
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
422
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
Albuquerque, New Mexico
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
Alexandria, Virginia 22304
2277
mi
from 91732
Alexandria, VA
Click here to add this to my saved trials
Brooklyn, New York 11215
2436
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
Brooksville, Florida
2126
mi
from 91732
Brooksville, FL
Click here to add this to my saved trials
Buena Park, California 90620
16
mi
from 91732
Buena Park, CA
Click here to add this to my saved trials
2211
mi
from 91732
Cary, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45212
1882
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
Coeur d'Alene, Idaho 83814
942
mi
from 91732
Coeur d'Alene, ID
Click here to add this to my saved trials
Dayton, Ohio 45439
1897
mi
from 91732
Dayton, OH
Click here to add this to my saved trials
Garden City, New York 11530
2452
mi
from 91732
Garden City, NY
Click here to add this to my saved trials
Greensboro, North Carolina
2151
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Hialeah, Florida 33016
2310
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33016
2310
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Hyattsville, Maryland 20782
2284
mi
from 91732
Hyattsville, MD
Click here to add this to my saved trials
Jeffersonville, Indiana 47130
1813
mi
from 91732
Jeffersonville, IN
Click here to add this to my saved trials
Jenkintown, Pennsylvania 19046
2377
mi
from 91732
Jenkintown, PA
Click here to add this to my saved trials
Kalamazoo, Michigan 49009
1833
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials
2429
mi
from 91732
Kingston, NY
Click here to add this to my saved trials
Kissimmee, Florida 34741
2186
mi
from 91732
Kissimmee, FL
Click here to add this to my saved trials
Los Angeles, California 90017
24
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Newburgh, Indiana 47630
1721
mi
from 91732
Newburgh, IN
Click here to add this to my saved trials
10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
1295
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
2433
mi
from 91732
Poughkeepsie, NY
Click here to add this to my saved trials
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
Rapid City, South Dakota 57702
1043
mi
from 91732
Rapid City, SD
Click here to add this to my saved trials
Savannah, Georgia 31406
2132
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
Suwanee, Georgia 30024
1933
mi
from 91732
Suwanee, GA
Click here to add this to my saved trials
Tampa, Florida
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Valley Village, California 91607
22
mi
from 91732
Valley Village, CA
Click here to add this to my saved trials
West Palm Beach, Florida 33407
2302
mi
from 91732
West Palm Beach, FL
Click here to add this to my saved trials
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
2126
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials
7186
mi
from 91732
Yerevan,
Click here to add this to my saved trials