BESIDE 905-EC-012 Version 2.0
Research type
Research Study
Full 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.
IRAS ID
131002
Contact name
Richard Parkinson
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd
Eudract number
2012-005401-41
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Overactive bladder syndrome (OAB) is a medical condition which causes sudden involuntary muscle contractions in the wall of the urinary bladder. This muscle contraction can cause a sudden and unstoppable need to urinate (urinary
urgency), often leading to unintentional loss of urine (urge incontinence).
It is a highly common condition and current drug therapy consists mainly of antimuscarinics. The pathophysiology of OAB is not fully understood, but it is likely that antimuscarinic drugs act by inhibiting the M3 subtype of muscarinic
receptors in the urinary bladder, leading to a decrease in involuntary detrusor contractions and increased bladder filling, thereby reducing storage symptoms. Muscarinic receptors are also found in other tissues such as the salivary
gland, intestine and eye, which mean that the use of antimuscarinic agents can give rise to anticholinergictype adverse events such as dry mouth, constipation and blurred vision.Development of drugs with a different mode of action to the muscarinic receptor antagonists may therefore result in treatment options with a better benefit/risk ratio than the currently available compounds. Recently, a new type of medication (mirabegron) has been approved for the treatment of OAB. Mirabegron works by activating the β3 adrenergic receptor in the detrusor muscle in the bladder, which leads to muscle relaxation and an increase in bladder capacity.
The purpose of this study is to see if combining Mirabegron with an antimuscarinic treatment (solifenacin) will be more effective in controlling incontinence than using the antimuscarinic treatment alone. The main objective is to evaluate the efficacy of solifenacin 5mg in combination with mirabegron 50mg (combination therapy) versus solifenacin 5mg monotherapy and solifenacin 10mg monotherapy. A total of 3408 subjects are required across approximately 300 centres across EU and non-EU countries.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0228
Date of REC Opinion
2 Jul 2013
REC opinion
Further Information Favourable Opinion