Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome

Overactive Bladder Clinical Trial

Official title:

A Phase 3, Parallel Group, Randomized, Double-Blind, Placebo Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138723
• Other study ID #: SP584
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2005
• Last updated: April 9, 2008
• Start date: October 2003
• Est. completion date: February 2005

Study information

• Verified date: March 2008
• 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 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial.

The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Overactive bladder syndrome

Exclusion Criteria:

• Less than 8 micturitions in 24 hours

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• SPM 907

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer