You are here

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.

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Radiant Research, Inc.
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT01302054
Pfizer
Completed
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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Neurogenic Urinary Bladder
NCT02501928
All Genders
6+
Years
Multiple Sites
Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and, Nosocomial Pneumonia (NP)
NCT02364284
All Genders
18+
Years
Multiple Sites
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.
  • Experimental: Fesoterodine
    Intervention: Drug: Fesoterodine 8 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
990
May 2012
May 2012   (Final data collection date for primary outcome measure)

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).
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

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now