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A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 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

- Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening
bladder diary prior to Start of Placebo run in visit (Visit 2)

- Mean number of micturition related urgency episodes >=3 per 24 hours as verified by
the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency
episodes are defined as those with Urinary Sensation Scale rating >=3)

- Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8
episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency
episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in
the bed time section of the bladder diary)

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

- A known recent history or previous diagnosis of any sleep disorder such as obstructive
sleep apnea, primary insomnia, periodic limb movement, parasomnia

- Nocturia due to other underlying uncontrolled conditions, such as congestive heart
failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

NCT00911937
Pfizer
Completed
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

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A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: Fesoterodine
    Fesoterodine 4mg and 8 mg tablets taken daily.
  • Drug: Placebo
    Placebo sham 4mg and 8 mg tables taken daily.
  • Experimental: Fesoterodine
    Intervention: Drug: Fesoterodine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
963
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
  • Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
  • Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

  • A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
  • Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00911937
A0221048
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

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

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