Fesoterodine Flexible Dose Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00536484
First received: September 25, 2007
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: Fesoterodine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2 and Week 6 ] [ Designated as safety issue: No ]
  • Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 896
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine (Double-Blind) 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 Comparator: Placebo (Double-Blind) Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536484

  Show 95 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00536484     History of Changes
Other Study ID Numbers: A0221014
Study First Received: September 25, 2007
Results First Received: March 12, 2009
Last Updated: September 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014