Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
NCT00691093
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Adult Trials: 18+ Years
- Patients older than 18 years
- Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
- Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
- Due to intolerance: persistent and/or unacceptable adverse events
- Hypersensitivity to the active substance or to peanut or soya or any of the
excipients.
- History of acute urinary retention (requiring catheterisation)
- Gastric retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Severe hepatic impairment (Child Pugh C)
- Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe
hepatic or renal impairment
- Severe ulcerative colitis
- Toxic megacolon.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy | |||
| Official Title | Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance. | |||
| Brief Summary | This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine. | |||
| Detailed Description | patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance) | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance) | |||
| Condition |
| |||
| Intervention | Drug: fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment Other Name: TOVIAZ | |||
| Study Groups/Cohorts | fesoterodine
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 | Completed | |||
| Actual Enrollment | 823 | |||
| Original Estimated Enrollment | 700 | |||
| Actual Study Completion Date | June 2009 | |||
| Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Slovakia | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00691093 | |||
| Other Study ID Numbers | A0221059 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | October 2018 | |||