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

• ClinicalTrials.gov Identifier: NCT00658684
• Recruitment Status: Completed
• First Posted: April 15, 2008
• Results First Posted: August 11, 2010
• Last Update Posted: October 13, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Overactive Bladder	Drug: fesoterodine fumarate	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 153 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: February 2008
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

1. 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 ]

   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

2. Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

   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

3. 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 ]

   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

4. 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 ]

   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

5. 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 ]

   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

6. Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

   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

7. Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 [ Time Frame: Week 28 and 52 ]

   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

8. Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 [ Time Frame: Week 28 and 52 ]

   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

9. 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 ]

   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
10. Change From Baseline in Grade of PPBC at Week 28 and 52 [ Time Frame: Week 28 and 52 ]

    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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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. 

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• ClinicalTrials.gov Identifier: NCT00658684
• Other Study ID Numbers: A0221006; A0221006
• First Posted: April 15, 2008
• Results First Posted: August 11, 2010
• Last Update Posted: October 13, 2010
• Last Verified: October 2010

Additional relevant MeSH terms:

Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Fesoterodine; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents