Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00658684

Purpose

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

Condition	Intervention	Phase
Overactive Bladder	Drug: fesoterodine fumarate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Fesoterodine Fesoterodine fumarate

Further study details as provided by Pfizer:

Primary Outcome Measures:

To assess the long term safety, tolerability and efficacy of Fesoterodine. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in mean number of micturitions, urgency urinary incontinence (UUI) episodes, incontinence episodes, urgency episodes and nighttime micturitions at Week 4, 8, 28 and 52. [ Time Frame: Weeks 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
Change from baseline in mean voided volume per micturitions at Week 4, 8, 28 and 52. [ Time Frame: Weeks 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
Safety measurement based on Adverse events, Vital signs, Clinical laboratory test, 12-lead ECG and Residual urine volume. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in score of King's Health Questionnaire (KHQ) and Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52. [ Time Frame: Weeks 28 and 52 ] [ Designated as safety issue: No ]
The number of subjects shifted in Patient Perception of Bladder Condition (PPBC) responses from baseline to Week 28 and 52 assessment and its percentage. [ Time Frame: Weeks 28 and 52 ] [ Designated as safety issue: No ]
Change from baseline in grade of PPBC at Week 28 and 52. [ Time Frame: Weeks 28 and 52 ] [ Designated as safety issue: No ]

Enrollment:	153
Study Start Date:	February 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine fumarate: Experimental	Drug: fesoterodine fumarate 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658684

Locations

Japan, Chiba-ken
Pfizer Investigational Site
Inegeku, Chibashi, Chiba-ken, Japan
Japan, Hyogo
Pfizer Investigational Site
Kaibara-cho, tanba-shi, Hyogo, Japan
Pfizer Investigational Site
Amagasaki-shi, Hyogo, Japan
Japan, Hyougo
Pfizer Investigational Site
Akashi-shi, Hyougo, Japan
Pfizer Investigational Site
Chuou-ku, koube-shi, Hyougo, Japan
Pfizer Investigational Site
Nishinomiya-shi, Hyougo, Japan
Japan, Kanagawa
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Japan, Kanagawaken
Pfizer Investigational Site
Kawasakishi, Kanagawaken, Japan
Japan, Nara
Pfizer Investigational Site
Nara-shi, Nara, Japan
Japan, Osaka
Pfizer Investigational Site
Osaka-shi, Osaka, Japan
Japan, Tokyo
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221006, A0221006
Study First Received:	April 9, 2008
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00658684 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on November 27, 2009