To explore the effects of fesoterodine when used in a flexible dose manner
- Male or female >18 years old
- OAB for >3 months
- Patients with conditions that would contraindicate for fesoterodine use
- Patients with significant hepatic and renal disease or other significant unstable
diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
etc.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | UK Study Assessing Flexible Dose Fesoterodine in Adults | |||
| Official Title ICMJE | A 12 Week, Multi-centre, Open Label Study To Evaluate The Efficacy, Tolerability And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder. | |||
| Brief Summary | To explore the effects of fesoterodine when used in a flexible dose manner | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Urinary Bladder, Overactive | |||
| Intervention ICMJE | Drug: Fesoterodine Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated | |||
| Study Arms ICMJE | Experimental: Treatment Arm Fesoterodine 4mg, escalating to 8mg as required Intervention: Drug: Fesoterodine | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 331 | |||
| Original Estimated Enrollment ICMJE | 300 | |||
| Actual Study Completion Date ICMJE | January 2010 | |||
| Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United Kingdom | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00806494 | |||
| Other Study ID Numbers ICMJE | A0221058 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2011 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
