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Fesoterodine Flexible Dose Study

NCT00536484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 896

Last updated 2009-09-15

Study results available
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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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536484 on ClinicalTrials.gov