- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00220363
A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
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
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 Overview
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Monheim, Germany
- Schwarz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Overactive Bladder Syndrome
Exclusion Criteria:
- less than 8 micturitions in 24 hours
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Axel Steinert, UCB Pharma
Publications and helpful links
General Publications
- Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
- Cardozo L, Khullar V, El-Tahtawy A, Guan Z, Malhotra B, Staskin D. Modeling dose-response relationships of the effects of fesoterodine in patients with overactive bladder. BMC Urol. 2010 Aug 19;10:14. doi: 10.1186/1471-2490-10-14.
- Staskin D, Michel MC, Nitti V, Morrow JD, Wang J, Guan Z. Efficacy of fesoterodine over 24 hours in subjects with overactive bladder. Curr Med Res Opin. 2010 Apr;26(4):813-8. doi: 10.1185/03007990903585707.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP583
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overactive Bladder Syndrome
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Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
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Taipei Veterans General Hospital, TaiwanRecruitingOveractive Bladder SyndromeTaiwan
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Buddhist Tzu Chi General HospitalUnknownOveractive Bladder SyndromeTaiwan
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Radboud University Medical CenterWithdrawn
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PfizerCompleted
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University Hospital, GhentAstellas Pharma Inc; MedtronicCompleted
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University Hospital, GhentTerminatedOveractive Bladder SyndromeBelgium
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Chung Shan Medical UniversityUnknownOveractive Bladder SyndromeTaiwan
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Far Eastern Memorial HospitalCompletedOveractive Bladder SyndromeTaiwan
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