A0221058 Fesoterodine Flexible Dose Regimen In Overactive Bladder

• Research type

  Research Study

• Full title

  A 12 WEEK, MULTICENTRE, OPEN LABEL STUDY TO EVALUATE THE EFFICACY, TOLERABILITY AND SAFETY OF A FESOTERODINE FLEXIBLE DOSE REGIMEN IN PATIENTS WITH OVERACTIVE BLADDER

• IRAS ID

  10251

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2008-004124-23

• ISRCTN Number

  N/A

• Research summary

  Fesoterodine fumarate has been developed for the treatment of the symptoms of over active bladder (OAB). The main symptoms of overactive bladder are, the need to go to the toilet many times throughout the day and night, an urgent feeling of having to go to the toilet immediately and sometimes leaking urine before reaching the toilet. Fesoterodine is available in 2 different strengths 4mg and 8 mg. This trial is designed to look at how fesoterodine is tolerated, how well it works and how safe it is when patients are allowed to increase the strength of the medication. It is not understood why patients might want to increase the strength of their medication so this trial is going to analyse some of the bothersome symptoms which cause patients to increase the strength of their medication. This is a 18 week study where the patient will have a 2 week screening period and 8 weeks of treatment followed by a 4 week follow up period. All patients will receive Fesoterodine and both the patient, study doctor and sponsor will know this. During the 18 weeks the patient will have 5 clinic visits. Pfizer UK is funding this research and its being carried out in the UK over approximately 41 sites

• REC name

  Wales REC 3

• REC reference

  08/MRE09/80

• Date of REC Opinion

  6 Jan 2009

• REC opinion

  Further Information Favourable Opinion