Phase II Study of Solifenacin and Mirabegron in Overactive Bladder

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder

• IRAS ID

  70279

• Contact name

  Marcus Drake

• Sponsor organisation

  Astellas Pharma Europe BV

• Eudract number

  2010-020601-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Overactive bladder is one of the major categories of lower urinary tract dysfunction and affects 16.6% of the adult population in the USA and 11.8% of the adult population in Europe with increasing incidence in the elderly. Solifenacin succinate has been available since 2003 for treatment of overactive bladder. Mirabegron belongs to a new class of the drugs being developed for treatment of overactive bladder. Mirabegron??s proposed indication is for the relief of symptoms of urinary frequency, urgency incontinence or urgency associated with OAB in adults. Mirabegron has recently been submitted for regulatory approval in Japan and applications for submission in Europe and the USA are currently under preparation.The purpose of this study is to examine the effectiveness, safety and tolerability of two medicines (solifenacin succinate and mirabegron)given in combination and as monotherapy, in the treatment of overactive bladder which is defined as urgency, with or without urge incontinence, usually with frequency and nocturia, which can be described as the OAB syndrome, urge syndrome or urgency-frequency syndrome. The main treatment options are conservative management (ie, bladder training and electrical stimulation) and pharmacotherapy, or a combination of both. Drugs are already available, but some of them may cause considerable side-effects and some are not effective in all people. The study will comprise of a screening assessment during which subjects will be asked to stop taking medications taken to treat over-active bladder or prohibited medications. There will then be a 2-week, single blind, placebo run-in period, followed by a randomized, double-blind, 12-week treatment period. Subjects will be randomized (approximately 1326 subjects) to one of twelve treatment arms and ten subjects in each treatment arm (120 subjects) will be asked to participate in a safety sub-study which will involve additional PK profiling, ECG and vital signs measurements at one visit.

• REC name

  West of Scotland REC 1

• REC reference

  11/S0703/4

• Date of REC Opinion

  8 Feb 2011

• REC opinion

  Favourable Opinion