MK-4618 in Patients with Overactive Bladder

• Research type

  Research Study

• Full title

  A Phase IIb Randomised, Placebo- and Active Comparator (Tolterodine)-Contolled, 2-Part Study of the Efficacy and Safety of KM-4618 in Patients With Overactive Bladder

• IRAS ID

  75033

• Contact name

  James Green

• Eudract number

  2010-022121-15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will assess the efficacy and safety of a new medication for the treatment of Overactive Bladder (OAB). OAB is defined as urinary urgency, with or without urge incontinence, usually associated with frequency and nocturia (the arousal from sleep to pass urine).Approximately 16% of the population in the US and EU, suffer from OAB. Prevalence increases with age, affecting approximately 1/3 of patients 75 years and older. Only 16-23% of patients with OAB symptoms seek professional help and of them only 50% are treated with a pharmacological agent. The predominant class of drugs used to treat OAB is antimuscarinics. However, clinical use of antimuscarinics is limited by modest efficacy and poor tolerability. Inability to tolerate antimuscarinics leaves patients with few alternative treatment options. Therefore, there is a need to identify alternative mechanisms for treatment.MK-4618 is a potent and selective beta-3 adrenergic receptor (β3AR) agonist. As of November 2010, no β3AR agonist has been approved for any indication but clinical data on the use of β3AR agonists in OAB are available. Cross-study comparisons of the clinical profiles of β3AR agonists with the current antimuscarinic market leader (tolterodine ER), suggest that β3AR agonists may possess similar or superior efficacy for the treatment of OAB with an improved tolerability profile. This adaptive study is designed to assess the dose-related clinical efficacy and tolerability of MK-4618, and concomitant dosing of MK-4618 and tolterodine ER 4 mg in patients with OAB. Part 1 of the study is a dose ranging study to assess the safety, tolerability, and efficacy of MK-4618 and proof of concept study for concomitant dosing of MK-4618 with tolterodine ER 4 mg. Part 2 continues to assess the safety and efficacy of concomitant dosing and also has the option of studying a lower dose of MK-4618 mono-therapy.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/0679

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Further Information Favourable Opinion