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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]
KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.

KHQ consists of the following domains:
- General health perceptions (GHP)
- Impact on life
- Role limitations
- Physical limitations
- Social limitations
- Personal relationships (PR)
- Emotions
- Sleep/energy
- Incontinence severity measures (ISM)
Change: mean at Week 28 and 52 minus mean at Baseline
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]
OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).

Change: mean at Week 28 and 52 minus mean at baseline
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]
The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:
1. no problems at all
2. some very minor problems
3. some minor problems
4. some moderate problems
5. severe problems
6. many severe problems
Change From Baseline in Grade of PPBC at Week 28 and 52 [ Time Frame: Week 28 and 52 ] [ Designated as safety issue: No ]
The PPBC assessment was rated on a 6-point scale as follows:
1. no problems at all
2. some very minor problems
3. some minor problems
4. some moderate problems
5. severe problems
6. many severe problems
Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.

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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00658684 History of Changes
Other Study ID Numbers:	A0221006, A0221006
Study First Received:	April 9, 2008
Results First Received:	July 14, 2010
Last Updated:	October 5, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 13, 2012