NCT00658684

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 11, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

1.5 years

First QC Date

April 9, 2008

Results QC Date

July 14, 2010

Last Update Submit

October 5, 2010

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume

    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.

    52 Weeks

Secondary Outcomes (10)

  • Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52

    Week 4, 8, 28 and 52

  • Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52

    Week 4, 8, 28 and 52

  • Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52

    Week 4, 8, 28 and 52

  • Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52

    Week 4, 8, 28 and 52

  • Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52

    Week 4, 8, 28 and 52

  • +5 more secondary outcomes

Study Arms (1)

Fesoterodine fumarate

EXPERIMENTAL
Drug: fesoterodine fumarate

Interventions

fesoterodine fumarateDRUG

4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Fesoterodine fumarate

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urinary urgency episodes \>=1 per day.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Inegeku, Chibashi, Chiba, Japan

Location

Pfizer Investigational Site

Akashi-shi, Hyōgo, Japan

Location

Pfizer Investigational Site

Amagasaki-shi, Hyōgo, Japan

Location

Pfizer Investigational Site

Chuou-ku, Koube-shi, Hyōgo, Japan

Location

Pfizer Investigational Site

Kaibara-cho, Tanba-shi, Hyōgo, Japan

Location

Pfizer Investigational Site

Nishinomiya-shi, Hyōgo, Japan

Location

Pfizer Investigational Site

Kawasakishi, Kanagawa, Japan

Location

Pfizer Investigational Site

Sagamihara-shi, Kanagawa, Japan

Location

Pfizer Investigational Site

Nara, Nara, Japan

Location

Pfizer Investigational Site

Osaka, Osaka, Japan

Location

Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shibuya-ku, Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 15, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 13, 2010

Results First Posted

August 11, 2010

Record last verified: 2010-10

Locations

JP(12)