Clinical trial NCT00658684: Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
Official title: An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.


Eligibility criteria: 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 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.

Primary outcomes:
measure: Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
timeFrame: Week 4, 8, 28 and 52
measure: Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
timeFrame: Week 4, 8, 28 and 52
measure: Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
timeFrame: Week 4, 8, 28 and 52
measure: Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
timeFrame: Week 4, 8, 28 and 52
measure: Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
timeFrame: Week 4, 8, 28 and 52
measure: Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
timeFrame: Week 4, 8, 28 and 52
measure: Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
timeFrame: Week 28 and 52
measure: Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
timeFrame: Week 28 and 52
measure: The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
timeFrame: Week 28 and 52
measure: Change From Baseline in Grade of PPBC at Week 28 and 52
timeFrame: Week 28 and 52
Other outcomes:
Locations:
city: Inegeku, Chibashi
country: Japan
facility: Pfizer Investigational Site
state: Chiba-ken
city: Amagasaki-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kaibara-cho, tanba-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Akashi-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Chuou-ku, koube-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Nishinomiya-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Kawasakishi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawaken
city: Sagamihara-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Nara-shi
country: Japan
facility: Pfizer Investigational Site
state: Nara
city: Osaka-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Edogawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: