A0221095 Study of 8mg of fesoterodine compared to 4mg of fesoterodine

• Research type

  Research Study

• Full title

  A 12-Week, Phase 4, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial in Overactive Bladder Subjects to Confirm the Efficacy of 8 mg Fesoterodine compared to 4 mg Fesoterodine

• IRAS ID

  80743

• Contact name

  John Christopher Raymond Hardwick

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2010-024181-22

• Clinicaltrials.gov Identifier

  01302067

• Research summary

  Overactive bladder (OAB) is a condition which effects between 10-15% of men and women. Patients who have the condition have an intense or sudden need to urinate (urgency) although they do not necessarily have a full bladder. Patients often need to urinate more often than normal and they may also suffer from incontinence (leakage of urine). Fesoterdine helps reduce these symptoms and has been approved for use in 35 countries. Fesoterodine is available in two different doses of 8mg and 4mg per day. Previous study results suggested that 8mg of fesoterodine is more effective in reducing the symptoms of OAB than 4mg. The current study has been designed to confirm the higher dose is more effective. The study evaluates the effectiveness of the two doses using a diary to record how often: subjects have urgency episodes, need to urinate and have incontinence episodes. In addition subjects are asked to complete questionnaires about how their bladder condition impacts their daily life. The objective of the study is provide information to doctors when deciding the best dose of medication for their patients. Subjects will be eligible for this study if they have OAB symptoms for at least 6 months, have an appropriate severity of condition, have no other conditions or use other medication that could put the subject at additional risk or interfere with the results of the study. The study is about 14 weeks long, with 3 clinic visits and 2 telephone contacts. It consists of a 2-week run-in period and a 12-week double-blind treatment period. During the treatment period 40% of subjects will be taking fesoterodine 8mg, 40% fesoterodine 4mg and 20% placebo. Subjects will not know which medication they are taking. The study is being sponsored by Pfizer Ltd and may be conducted at hospitals and GP sites.

• REC name

  West of Scotland REC 1

• REC reference

  11/WS/0037

• Date of REC Opinion

  8 Sep 2011

• REC opinion

  Favourable Opinion