A0221094 Fesoterodine in patients without enough Tolterodine response

• Research type

  Research Study

• Full title

  A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study of Fesoterodine 8 mg in Overactive Bladder Patients with Sub-Optimal Response to Tolterodine 4 mg ER

• IRAS ID

  78652

• Contact name

  Malcolm George Lucas

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2010-024179-18

• ISRCTN Number

  .

• Clinicaltrials.gov Identifier

  .

• Research summary

  This is a study of men and women with overactive bladder (OAB) with leakage of urine. The aim of the study is to find out if the medicine fesoterodine works in patients who did not have enough symptom relief from the medicine tolterodine. Patients participating in the study are known as "subjects".A common treatment for OAB is a class of medicines called anti-muscarinics. Both fesoterodine and tolterodine belong to this class of medicine. In general practice, if a medicine is not giving a patient enough symptom relief from OAB, an alternative anti-muscarinic will be given in the hope that the patient will have an improved response. However, the evidence for this treatment approach by doctors is not well supported by controlled clinical studies. This study aims to provide that evidence.The study has 3 distinct phases; a 2 week washout phase where subjects will be required to stop any current OAB treatment, a 2 week open label treatment phase with the medicine tolterodine and then a 12 week treatment phase where patients will receive either placebo (an inactive medicine) or the medicine fesoterodine. Subjects will not know what treatment they have been given during this phase and the chance of receiving placebo is 50%. During the study, subjects will need to attend the study doctor??s clinic 4 times, and complete a symptom diary as well as several questionnaires.To qualify for the study subjects will be assessed by the study doctor to confirm certain criteria following their consent. A key criterion is measuring OAB symptom burden. This is assessed by a 3 day diary where subjects will record the number of times they urinate and whether they have had accidental urine leakage.This study is being sponsored by Pfizer Ltd and is being conducted in 24 other countries and in over 200 clinical sites.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  11/WM/0266

• Date of REC Opinion

  26 Oct 2011

• REC opinion

  Further Information Favourable Opinion