Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00658684 | Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. | PHASE3 | COMPLETED | 153 | — | — | Feb 1, 2008 | Aug 1, 2009 | Oct 13, 2010 | 12 | Japan |
| NCT00536484 | Fesoterodine Flexible Dose Study | PHASE3 | COMPLETED | 896 | — | — | Aug 1, 2007 | Mar 1, 2008 | Sep 15, 2009 | 95 | United States |
| NCT00444925 | Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB) | PHASE3 | COMPLETED | 1,712 | — | — | Apr 1, 2007 | Jul 1, 2008 | Mar 24, 2015 | 178 | United States, Belgium +27 |
| NCT00425100 | A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients | PHASE3 | COMPLETED | 516 | — | — | Jan 1, 2007 | Oct 1, 2007 | Dec 5, 2018 | 60 | United States, Belgium +7 |
| NCT00857896 | Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years | PHASE2 | COMPLETED | 21 | — | — | Mar 1, 2009 | Dec 1, 2010 | Nov 24, 2011 | 9 | United States |
| NCT00561951 | Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder. | PHASE2 | COMPLETED | 951 | — | — | Nov 1, 2007 | Jan 1, 2009 | Jul 14, 2011 | 65 | Hong Kong, Japan +2 |
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
| Arm | Type | Description |
|---|---|---|
| Fesoterodine fumarate | EXPERIMENTAL | - |
| Fesoterodine (Double-Blind) | EXPERIMENTAL | - |
| Placebo (Double-Blind) | PLACEBO_COMPARATOR | - |
| Fesoterodine | EXPERIMENTAL | Tablets |
| Placebo | PLACEBO_COMPARATOR | Tablets and capsules |
| Tolterodine | ACTIVE_COMPARATOR | Capsules |
| Open Label-fesoterodine | EXPERIMENTAL | Single treatment study arm. |
| Fesoterodine once daily | EXPERIMENTAL | - |
| Fesoterodine fumarate 4 mg (Double-Blind) | EXPERIMENTAL | - |
| Fesoterodine fumarate 8 mg (Double-Blind) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| fesoterodine fumarate | DRUG | 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks |
| Fesoterodine | DRUG | 4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing. |
| Placebo | DRUG | Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing. |
| tolterodine tartrate | DRUG | 4 mg once daily (OD) for 12 weeks |
Inclusion Criteria: * Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urinary urgency episodes \>=1 per day. Exclusion Criteria: * Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excip...