Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome
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| ClinicalTrials.gov Identifier: NCT00220376 |
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Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: November 24, 2008
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This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.
Subjects completing the 12 week treatment period of SP584 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which can be followed on an annual basis.
The primary variables are long-term safety and tolerability, measured by observation and assessment of adverse events and duration on therapy. Further safety variables include the assessment of laboratory parameters, changes in ECG, physical exams and measurement of residual urine.
Secondary efficacy variables included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overactive Bladder Syndrome | Drug: SPM 907 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome |
| Study Start Date : | April 2004 |
| Actual Primary Completion Date : | July 2007 |
| Actual Study Completion Date : | July 2007 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
Inclusion Criteria:
- Overactive Bladder Syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220376
| United States, North Carolina | |
| Schwarz | |
| RTP, North Carolina, United States | |
| Study Director: | Brooke Derby | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00220376 History of Changes |
| Other Study ID Numbers: |
SP739 |
| First Posted: | September 22, 2005 Key Record Dates |
| Last Update Posted: | November 24, 2008 |
| Last Verified: | November 2008 |
Additional relevant MeSH terms:
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Syndrome Urinary Bladder, Overactive Disease Pathologic Processes Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms |
Fesoterodine Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |