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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01908829




Registration number
NCT01908829
Ethics application status
Date submitted
24/07/2013
Date registered
26/07/2013
Date last updated
15/08/2018

Titles & IDs
Public title
A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)
Scientific title
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
Secondary ID [1] 0 0
2012-005401-41
Secondary ID [2] 0 0
905-EC-012
Universal Trial Number (UTN)
Trial acronym
BESIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Diseases 0 0
Urinary Bladder Overactive 0 0
Urologic Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - mirabegron 25 mg
Treatment: Drugs - mirabegron 50 mg
Treatment: Drugs - solifenacin 5 mg
Treatment: Drugs - solifenacin 10 mg
Treatment: Drugs - mirabegron 25 mg matching placebo
Treatment: Drugs - mirabegron 50 mg matching placebo
Treatment: Drugs - solifenacin 5 mg matching placebo
Treatment: Drugs - solifenacin 10 mg matching placebo

Experimental: Combination (solifenacin + mirabegron) - Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.

Active Comparator: Solifenacin 5 mg - Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period

Active Comparator: Solifenacin 10 mg - Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.


Treatment: Drugs: mirabegron 25 mg
Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

Treatment: Drugs: mirabegron 50 mg
Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

Treatment: Drugs: solifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.

Treatment: Drugs: solifenacin 10 mg
Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.

Treatment: Drugs: mirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

Treatment: Drugs: mirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

Treatment: Drugs: solifenacin 5 mg matching placebo
Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

Treatment: Drugs: solifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [1] 0 0
Baseline and end of treatment (up to 12 weeks)
Secondary outcome [1] 0 0
Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [1] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [2] 0 0
Change From Baseline in Mean Number of Micturitions Per 24 Hours
Timepoint [2] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [3] 0 0
Number of Incontinence Episodes Reported During the 3-Day Diary
Timepoint [3] 0 0
Weeks 4, 8 and 12
Secondary outcome [4] 0 0
Change From Baseline in Mean Volume Voided (MVV) Per Micturition
Timepoint [4] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [5] 0 0
Change From Baseline to EoT in Corrected Micturition Frequency (CMF)
Timepoint [5] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [6] 0 0
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours
Timepoint [6] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [7] 0 0
Number of UI Episodes Reported During the 3-Day Diary
Timepoint [7] 0 0
Weeks 4, 8 and 12
Secondary outcome [8] 0 0
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Timepoint [8] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [9] 0 0
Change From Baseline in Mean Number of Pads Per 24 Hours
Timepoint [9] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [10] 0 0
Number of Pads Used During the 3-Day Diary
Timepoint [10] 0 0
Weeks 4, 8 and 12
Secondary outcome [11] 0 0
Change From Baseline in Mean Number of Nocturia Episodes
Timepoint [11] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [12] 0 0
Number of Nocturia Episodes Reported Over 3-Day Diary
Timepoint [12] 0 0
Weeks 4, 8 and 12
Secondary outcome [13] 0 0
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility
Timepoint [13] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [14] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care
Timepoint [14] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [15] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities
Timepoint [15] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [16] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort
Timepoint [16] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [17] 0 0
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression
Timepoint [17] 0 0
Baseline and EoT (up to 12 weeks)
Secondary outcome [18] 0 0
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score
Timepoint [18] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [19] 0 0
Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score
Timepoint [19] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [20] 0 0
Change From Baseline in OAB-q HRQL Subscale Score: Coping
Timepoint [20] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [21] 0 0
Change From Baseline in OAB-q HRQL Subscale Score: Concern
Timepoint [21] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [22] 0 0
Change From Baseline in OAB-q HRQL Subscale Score: Sleep
Timepoint [22] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [23] 0 0
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction
Timepoint [23] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [24] 0 0
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score
Timepoint [24] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [25] 0 0
Change From Baseline in Patient Perception Bladder Control (PPBC) Score
Timepoint [25] 0 0
Baseline and weeks 4, 8 & 12
Secondary outcome [26] 0 0
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)
Timepoint [26] 0 0
End of treatment (up to 12 weeks)
Secondary outcome [27] 0 0
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [27] 0 0
Weeks 4, 8 and 12
Secondary outcome [28] 0 0
Percentage of Participants With Zero Incontinence Episodes Postbaseline
Timepoint [28] 0 0
Weeks 4, 8 and 12
Secondary outcome [29] 0 0
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline
Timepoint [29] 0 0
Weeks 4, 8 and 12
Secondary outcome [30] 0 0
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score
Timepoint [30] 0 0
Weeks 4, 8 and 12
Secondary outcome [31] 0 0
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score
Timepoint [31] 0 0
Weeks 4, 8 and 12
Secondary outcome [32] 0 0
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC
Timepoint [32] 0 0
Weeks 4, 8 and 12
Secondary outcome [33] 0 0
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC
Timepoint [33] 0 0
Weeks 4, 8 and 12
Secondary outcome [34] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [34] 0 0
From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)
Secondary outcome [35] 0 0
Change From Baseline in Post Void Residual (PVR) Volume
Timepoint [35] 0 0
Baseline and weeks 4, 8 & 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/11/2014
Sample size
Target
Accrual to date
Final
2174
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site: 61006 - Adelaide
Recruitment hospital [2] 0 0
Site: 61001 - Kogarah, Sydney
Recruitment hospital [3] 0 0
Site: 61016 - Victoria
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Kogarah, Sydney
Recruitment postcode(s) [3] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
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Nebraska
Country [11] 0 0
United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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South Dakota
Country [17] 0 0
United States of America
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Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Armenia
State/province [19] 0 0
Yerevan
Country [20] 0 0
Austria
State/province [20] 0 0
Graz
Country [21] 0 0
Austria
State/province [21] 0 0
Innsbruck
Country [22] 0 0
Austria
State/province [22] 0 0
Linz
Country [23] 0 0
Austria
State/province [23] 0 0
Vienna
Country [24] 0 0
Austria
State/province [24] 0 0
Wels
Country [25] 0 0
Belgium
State/province [25] 0 0
Anderlecht
Country [26] 0 0
Belgium
State/province [26] 0 0
Deurne
Country [27] 0 0
Belgium
State/province [27] 0 0
Edegem
Country [28] 0 0
Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
State/province [30] 0 0
Liege
Country [31] 0 0
Belgium
State/province [31] 0 0
Roeselare
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Canada
State/province [32] 0 0
Barrie
Country [33] 0 0
Canada
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Bathurst
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Canada
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Brampton
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Canada
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Granby
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Kelowna
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Kitchener
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Sherbrooke
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Toronto
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Canada
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Victoriaville
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Victoria
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Czechia
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Brno
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Czechia
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Melnik
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Praha 2
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Praha 4
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Aarhus N
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Frederiksberg
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T'bilisi
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Hagenow
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Henningsdorf
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Hettstedt
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Koblenz
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Lutherstadt Eisleben
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Reutlingen
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Sangerhausen
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Athens
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Heraklion, Crete
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Patras
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Csongrad
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Hajduszoboszlo
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Nyiregyhaza
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Mullingar
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Tralee
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Haifa
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Tel Hashomer
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Italy
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Avellino
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Italy
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Cantanzaro
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Italy
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Firenze
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Italy
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Perugia
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Italy
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Treviglio (BG)
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Italy
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Varese
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Lebanon
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Beirut
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Netherlands
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Amsterdam
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Norway
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Bekkestua
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Norway
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Tonsberg
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Norway
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Trondheim
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Poland
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Kolbuszowa Dolna
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Piaseczno
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Poland
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Warszawa
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Portugal
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Lisbon
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Portugal
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Matosinhos
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Portugal
State/province [107] 0 0
Porto
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Portugal
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Setubal
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Portugal
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Tomar
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Romania
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Bucharest
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Romania
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Craiova
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Romania
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Judetul Ilfov
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Romania
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Oradea
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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Rostove-on-Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Bratislava
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Slovakia
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Kosice
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Michalovce
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Slovakia
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Nove Zamky
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Slovakia
State/province [123] 0 0
Piestany
Country [124] 0 0
Slovakia
State/province [124] 0 0
Poprad
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Slovakia
State/province [125] 0 0
Zilina
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Slovenia
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Ljubljana
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Slovenia
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Maribor
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Slovenia
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Ptuj
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Getafe (Madrid)
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Spain
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Madrid
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Spain
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Mendaro
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Spain
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Miranda de Ebro
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Spain
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West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Europe Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01908829
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Study Manager
Address 0 0
Astellas Pharma Europe Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries