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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Homewood, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive 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

- Adult overactive bladder (OAB) patients who present with OAB symptoms, including
urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

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

- Patients with conditions that would contraindicate for fesoterodine use, e.g,
hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of
the excipients, urinary retention, and gastric retention.

- Patients with significant hepatic and renal disease or other significant unstable
diseases.

- OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
etc.

NCT00444925
Pfizer
Completed
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: fesoterodine fumarate
    4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
  • Drug: placebo
    once daily (OD)for 12 weeks
  • Drug: tolterodine tartrate
    4 mg once daily (OD) for 12 weeks
  • Experimental: Fesoterodine
    Tablets
    Intervention: Drug: fesoterodine fumarate
  • Placebo Comparator: Placebo
    Tablets and capsules
    Intervention: Drug: placebo
  • Active Comparator: Tolterodine
    Capsules
    Intervention: Drug: tolterodine tartrate
Corcos J, Angulo JC, Garely AD, Carlsson M, Gong J, Guan Z; Fesoterodine Assessment and Comparison Versus Tolterodine (FACT) Study Group. Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. Curr Med Res Opin. 2011 May;27(5):1059-65. doi: 10.1185/03007995.2011.565044. Epub 2011 Mar 23.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1712
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

  • Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
  • Patients with significant hepatic and renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Canada,   Chile,   Colombia,   Costa Rica,   Czech Republic,   Denmark,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Malaysia,   Norway,   Peru,   Poland,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Ukraine,   United States
Netherlands
 
NCT00444925
A0221008
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

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

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