| November 19, 2007 |
| February 9, 2009 |
| November 2007 |
| January 2009 (final data collection date for primary outcome measure) |
| Change from baseline in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
| To assess the efficacy of fesoterodine 4 mg and 8 mg as compared to placebo in subjects with overactive bladder syndrome after 12 weeks of treatment and to determine the recommended dose in subjects with OAB. |
| Complete list of historical versions of study NCT00561951 on ClinicalTrials.gov Archive Site |
- Safety measurement based on Adverse events, Vital signs, Clinical laboratory test, 12-lead ECG and Residual urine volume. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
- The number of subjects shifted in Patient Perception of Bladder Condition (PPBC) responses from baseline to Week 12 assessment and its percentage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean number of micturitions, incontinence episodes, urgency episodes and nighttime micturitions at Week 2, 4, 8 and 12. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
- Change from baseline in mean number of urgency urinary incontinence (UUI) episodes at Week 2, 4 and 8. [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
- Change from baseline in score of King's Health Questionnaire (KHQ) and Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Change from baseline in grade of PPBC at week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean voided volume per micturitions at Week 2, 4, 8 and 12. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
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- To assess the safety and tolerability of fesoterodine 4 mg and 8 mg as compared to placebo in subjects with OAB after 12 weeks of treatment.
- To investigate pharmacokinetics of 5-hydroxymethyl tolterodine (SPM7605), active metabolite of fesoterodine in patients with OAB who take fesoterodine 4 mg and 8 mg at weeks 4 and 12.
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| Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder. |
| A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder. |
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Overactive Bladder |
- Drug: fesoterodine fumarate
- Drug: Placebo
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| Completed |
| 900 |
| January 2009 |
| January 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.
Exclusion Criteria:
- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
- Patient has a known neurological disease influencing bladder function.
- Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
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| Both |
| 20 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Hong Kong, Japan, Korea, Republic of, Taiwan |
| |
| NCT00561951 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A0221005 |
| Pfizer |
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer |
| February 2009 |
