| A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine. |
| 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 Extended Release (ER). |
| Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens. |
| Not Provided |
| Interventional |
| Phase 4 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment |
| Urinary Bladder, Overactive |
- Drug: Fesoterodine 8 mg
Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
Other Name: Toviaz
- Drug: Placebo
Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.
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| Kaplan SA, Cardozo L, Herschorn S, Grenabo L, Carlsson M, Arumi D, Crook TJ, Whelan L, Scholfield D, Ntanios F; Assessment of Fesoterodine after Tolterodine ER (AFTER) Study Group. Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER. Int J Clin Pract. 2014 Sep;68(9):1065-73. doi: 10.1111/ijcp.12464. Epub 2014 Jun 4. |
| |
| Completed |
| 990 |
| May 2012 |
| May 2012 (Final data collection date for primary outcome measure) |
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Inclusion Criteria:
- Diagnosis of overactive bladder with symptoms for at least 6 months.
- Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
- Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception
Exclusion Criteria:
- Conditions or prior treatment that may also affect bladder function
- Clinically significant urinary tract infection (UTI)
- Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
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| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Bulgaria, Canada, Czech Republic, Egypt, Finland, Germany, Hungary, Korea, Republic of, Mexico, Poland, Russian Federation, South Africa, Sweden, Ukraine, United States |
| Greece, Italy, United Kingdom |
| |
| NCT01302054 |
| A0221094 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| March 2013 |
