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 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period. Two primary efficacy variables will be assessed for submission in the...
Date First Received: August 30, 2005
Last Updated: April 29, 2008
Verified by: Pfizer, April 2008
Clinical Trial Phase: Phase 3 | Start Date: January 2004
Overall Status: Completed
Brief Summary
Official Title: “A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome”
Condition Keyword(s):
Intervention(s):
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 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) 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 most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Study Primary Completion Date: February 2005
Intervention(s) in this Clinical Trial
- Drug: SPM 907
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Overactive Bladder Syndrome
Exclusion Criteria:
- less than 8 micturitions in 24 hours
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Axel Steinert Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00220363
Study ID Number: SP583
ClinicalTrials.gov Identifier: NCT00220363
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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