A study to evaluate the efficacy and safety of mirabegron compared to solifenacin in patients with overactive bladder who are previously treated with another medicine but were not satisfied with that treatment.
- Conditions
- Overactive bladderMedDRA version: 14.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857Therapeutic area: Body processes [G] - Physical Phenomena [G01]
- Registration Number
- EUCTR2011-005713-37-SI
- Lead Sponsor
- Astellas Pharma Europe Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1992
1.Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for = 3 months prior to the Screening Visit.
2.Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB.
3.The perception of the last treatment satisfaction on a 7 item Likert scale is extremely, very, or slightly dissatisfied.
4.Subject is willing and able to complete a micturition diary and questionnaires.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1394
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 598
1.Subject has clinically significant Bladder Outlet Obstruction (BOO).
2.Subject has neurogenic bladder.
3.Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor.
4.Subject has an indwelling catheter or practices intermittent self-catheterization.
5.Subject has diabetic neuropathy.
6.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.
7.Subject has moderate to severe hepatic impairment.
8.Subject has severe renal impairment or End Stage Renal disease.
9.Subject has severe uncontrolled hypertension.
10.Subject’s last anti-muscarinic treatment was solifenacin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.;Secondary Objective: To assess the safety and tolerability of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.;Primary end point(s): Change from baseline in the mean number of micturitions per 24 hours, based on a 3-day micturition diary.;Timepoint(s) of evaluation of this end point: Day 1, Week 4, Week 8, Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of subjects reporting at least one treatment-emergent adverse event of dry mouth, constipation or blurred vision during double-blind treatment period. ;Timepoint(s) of evaluation of this end point: Day 1 - week 12