XEN-D0501 for treatment of idiopatic overactive bladder

• Research type

  Research Study

• Full title

  A Phase 2a, multicentre, parallel-group, randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of 2 doses of XEN-D0501 in the treatment of idiopathic overactive bladder (OAB).

• IRAS ID

  68001

• Contact name

  Christopher Chapple

• Sponsor organisation

  Xention Limited

• Eudract number

  2010-022611-19

• ISRCTN Number

  n/a

• Research summary

  This is a Phase 2a, multicentre, double-blind, placebo-controlled study in patients with idiopathic overactive bladder (OAB), a disorder which afflicts people worldwide with a rate of incidence similar to that of common conditions such as arthritis and sinusitis. The study is designed to evaluate the safety and efficacy of twice daily dosing with 2 doses of XEN-D0501, a potent and selective antagonist of TRPV1 receptors, which are involved in monitoring mechanism of the bladder volume and the amplitude of bladder contraction. The study consists of 2 periods. The first period is a 14 day single-blind run-in period, when all study subjects will receive placebo. Subjects who continue to be eligible for the study at the end of run-in period will be randomized into three groups to be treated twice daily with XEN-D0501 2mg, XEN-D0501 4mg or placebo, correspondingly. The double blind treatment period of the study will last for 28 days. All test performed during the study will be normal clinical procedures (assessment of blood chemistry and hematology, urinalysis, electrocardiography, ultrasound). A placebo arm is included as a comparison to allow an objective assessment of the ability of XEN-D0501 to reduce urinary symptoms in patients with OAB. As OAB is not life threatening disease this poses no long term risk to the subjects.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/92

• Date of REC Opinion

  7 Jan 2011

• REC opinion

  Further Information Favourable Opinion