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NCT00536484 Clinical Trial

Fesoterodine Flexible Dose Study

Overactive Bladder Clinical Trial

Official title:
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00536484
Other study ID # A0221014
Secondary ID
Status Completed
Phase Phase 3
First received September 25, 2007
Last updated September 10, 2009
Start date August 2007
Est. completion date March 2008

Study information
Verified date September 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

Recruitment information / eligibility
Status Completed
Enrollment 896
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Overactive bladder symptoms for greater than or equal to 3 months.

- Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.

- Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

- Contraindication to fesoterodine (antimuscarinics).

- Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).

- Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.

- Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fesoterodine
4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
• Placebo
Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Locations
Country Name City State
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Arlington Virginia
United States Pfizer Investigational Site Aventura Florida
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Bel Air Maryland
United States Pfizer Investigational Site Bethany Oklahoma
United States Pfizer Investigational Site Bonita Springs Florida
United States Pfizer Investigational Site Bristol Tennessee
United States Pfizer Investigational Site Bryan Texas
United States Pfizer Investigational Site Cary North Carolina
United States Pfizer Investigational Site Chandler Arizona
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Corpus Christi Texas
United States Pfizer Investigational Site Cranston Rhode Island
United States Pfizer Investigational Site Cumberland Rhode Island
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Englewood Colorado
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Garden City New York
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Iowa City Iowa
United States Pfizer Investigational Site Jeffersonville Indiana
United States Pfizer Investigational Site Johnson City Tennessee
United States Pfizer Investigational Site Johnson City Tennessee
United States Pfizer Investigational Site Kingston New York
United States Pfizer Investigational Site Lake Worth Florida
United States Pfizer Investigational Site Lansdale Pennsylvania
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Longview Texas
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Madisonville Kentucky
United States Pfizer Investigational Site Manlius New York
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Milford Massachusetts
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Mountlake Terrace Washington
United States Pfizer Investigational Site Mt. Pleasant South Carolina
United States Pfizer Investigational Site Naples Florida
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Britain Connecticut
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New Tazewell Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newburgh Indiana
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Norman Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Paw Paw Michigan
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Peoria Arizona
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Picayune Mississippi
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Poughkeepsie New York
United States Pfizer Investigational Site Pratt Kansas
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Rancho Cordova California
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Royal Oak Michigan
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sellersville Pennsylvania
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site State College Pennsylvania
United States Pfizer Investigational Site Stuart Florida
United States Pfizer Investigational Site Syracuse New York
United States Pfizer Investigational Site Tallahassee Florida
United States Pfizer Investigational Site Troy Michigan
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Warwick Rhode Island
United States Pfizer Investigational Site West Yarmouth Massachusetts
United States Pfizer Investigational Site Williamsville New York
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. Baseline and Week 12 No
Secondary Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline Baseline, Week 2 and Week 6 No
Secondary Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale Baseline and Week 12 No
Secondary Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales Baseline and Week 12 No
Secondary Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
Secondary Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline Baseline, Week 2, Week 6 and Week 12 No
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Completed NCT00910845 - Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence Phase 3

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