A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01638000
• Date of registration: 09/07/2012
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Europe Ltd.
• Public title: A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment. BEYOND
• Scientific title: A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy
• Date of first enrolment: June 2012
• Target sample size: 1887
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01638000
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Armenia, Austria, Belarus, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom

Contacts

• Name: Clinical Study Manager
• Affiliation: Astellas Pharma Europe Ltd.

Key inclusion & exclusion 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 urgency
incontinence) for at least 3 months

- Subject is currently or has previously received at least one antimuscarinic agent
intended to treat their OAB. The last antimuscarinic must have been taken for at least
4 weeks and taken within 6 months prior to the Screening Visit

Exclusion Criteria:

- Female subject is breastfeeding, pregnant, intends to become pregnant during the
study, or of childbearing potential is sexually active and not practicing a highly
reliable method of birth control

- Subject has neurogenic bladder

- 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)

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

- Subject has diabetic neuropathy

- Subject has evidence of a symptomatic urinary tract infection, chronic inflammation
such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or
previous or current malignant disease of the pelvic organs

- Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe
ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition
which makes the use of anticholinergics contraindicated

- The subject is currently receiving or has a history of treatment with intravesical
botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior
to screening

- Subject receives non-drug treatment including electro-stimulation therapy (with the
exception of a bladder training program or pelvic floor exercises which started more
than 30 days prior to screening)

- Subject has moderate to severe hepatic impairment

- Subject has severe renal impairment or end stage renal disease

- Subject has severe uncontrolled hypertension

- Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known
history of QT prolongation or currently taking medication known to prolong the QT
interval

- Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of
the inactive ingredients

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

- Subject has been treated with an experimental device within 30 days or received an
experimental agent within the longer of 30 days or five half-lives

- Subject is using prohibited medications which cannot be stopped safely at the
Screening Visit. Subject is excluded if using restricted medications not meeting
protocol-specified criteria

- Subject's last antimuscarinic treatment was solifenacin



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Urinary Bladder Diseases

Urologic Diseases

Urinary Bladder, Overactive

Intervention(s)

Drug: Mirabegron

Drug: Solifenacin succinate

Primary Outcome(s)

Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours [Time Frame: Baseline and final visit (up to Week 12)]

Secondary Outcome(s)

Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and final visit (up to Week 12)]

Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 12]

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale [Time Frame: Baseline and Week 12]

Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 4]

Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 8]

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours [Time Frame: Baseline and Week 4, Week 8, Week 12]

Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit [Time Frame: Week 4, Week 8, Week 12]

Percentage of Participants With Improvement in PPBC: =1 Point Improvement at Week 12 and Final Visit [Time Frame: Baseline to Week 12]

Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and final visit (up to Week 12)]

Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 4]

Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 8]

Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 12]

Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 12]

Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 12]

Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire [Time Frame: Baseline and Week 4]

Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 4]

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q [Time Frame: Baseline and Week 4, Week 8, Week 12]

Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment [Time Frame: Baseline and Week 4, Week 8, Week 12]

Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period [Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)]

Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: =1, =2, =3, =4, =5, and 6-point Improvement From Baseline to Week 12 [Time Frame: Baseline to Week 12]

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours [Time Frame: Baseline and Week 4, Week 8, Week 12]

Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency [Time Frame: Baseline and Week 4, Week 8, Week 12]

Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit [Time Frame: Week 4, Week 8, Week 12]

Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 12]

Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit [Time Frame: Week 4, Week 8, Week 12]

Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 8]

Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours [Time Frame: Baseline and Week 4, Week 8, Week 12]

Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit [Time Frame: Week 4, Week 8, Week 12]

Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours [Time Frame: Baseline and Week 4, Week 8, Week 12]

Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and final visit (up to Week 12)]

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) [Time Frame: Baseline and Week 12]

Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit [Time Frame: Week 4, Week 8, Week 12]

Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and final visit (up to Week 12)]

Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 8]

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) [Time Frame: Baseline and Week 4, Week 8, Week 12]

Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: =1, =2, =3, =4, =5, and 6-point Improvement From Baseline to Final Visit [Time Frame: Baseline to final visit (up to Week 12)]

Percentage of Participants With Major Improvement in PPBC: =2 Point Improvement at Week 12 and Final Visit [Time Frame: Baseline to Week 12]

Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment [Time Frame: Baseline and Week 4, Week 8 , Week 12]

Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and final visit (up to Week 12)]

Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 4]

Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire [Time Frame: Baseline and Week 8]

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) [Time Frame: Baseline and Week 4, Week 8, Week 12]

Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit [Time Frame: Week 4, Week 8, Week 12]

Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: =10 Points Improvement in OAB-q at Week 12 and Final Visit [Time Frame: Baseline to Week 12]

Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit [Time Frame: Week 4, Week 8, Week 12]

Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: = 10 Points Improvement in OAB-q at Week 12 and Final Visit [Time Frame: Baseline to Week 12]

Secondary ID(s)

2011-005713-37

178-EC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/08/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01638000